{"id":54153,"date":"2018-09-28T01:00:00","date_gmt":"2018-09-30T01:52:57","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/30\/%e3%80%90fda%e3%80%91fda2018%e5%b9%b4483%e6%8a%a5%e5%91%8a%e4%b8%8e%e8%ad%a6%e5%91%8a%e4%bf%a1%e6%b1%87%e6%80%bb%e7%af%87%ef%bc%9a%e6%95%b0%e6%8d%ae%e5%8f%af%e9%9d%a0%e6%80%a7%e7%bc%ba%e9%99%b7\/"},"modified":"2018-09-30T09:52:59","modified_gmt":"2018-09-30T01:52:59","slug":"%e3%80%90fda%e3%80%91fda2018%e5%b9%b4483%e6%8a%a5%e5%91%8a%e4%b8%8e%e8%ad%a6%e5%91%8a%e4%bf%a1%e6%b1%87%e6%80%bb%e7%af%87%ef%bc%9a%e6%95%b0%e6%8d%ae%e5%8f%af%e9%9d%a0%e6%80%a7%e7%bc%ba%e9%99%b7","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/54153\/","title":{"rendered":"\u3010FDA\u3011FDA2018\u5e74483\u62a5\u544a\u4e0e\u8b66\u544a\u4fe1\u6c47\u603b\u7bc7\uff1a\u6570\u636e\u53ef\u9760\u6027\u7f3a\u9677"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<section class=\"Powered-by-XIUMI V5\"  style=\"line-height: 25.6px;white-space: normal;box-sizing: border-box;\">\n<section class=\"\" style=\"margin-top: 10px;margin-bottom: 10px;box-sizing: border-box;\">\n<section class=\"\" style=\"border: 57px inset;-webkit-border-image: url(&quot;https:\/\/mmbiz.qpic.cn\/mmbiz_png\/odCrwTSU6JhDjFXy9pHMo1wQkjAEVoS4iceBr3GCy9GbjOTJZuiaWoFrY70iaM4CLLiaJpeZV5iat1HayVeZ24kZkbw\/640?wx_fmt=png&quot;) 100 fill;box-sizing: border-box;\">\n<section class=\"Powered-by-XIUMI V5\"  style=\"box-sizing: border-box;\">\n<section class=\"\" style=\"box-sizing: border-box;\">\n<section class=\"\" style=\"padding-right: 5px;display: inline-block;vertical-align: top;width: 315.234px;box-sizing: border-box;\">\n<section class=\"Powered-by-XIUMI V5\"  style=\"box-sizing: border-box;\">\n<section class=\"\" style=\"margin-top: 30px;margin-bottom: 10px;box-sizing: border-box;\">\n<section class=\"\" style=\"margin-top: -2.25em;margin-right: 5px;padding-top: 5px;box-sizing: border-box;\">\n<section class=\"\" style=\"box-sizing: border-box;background-color: rgb(247, 247, 247);\">\n<section class=\"Powered-by-XIUMI V5\"  style=\"box-sizing: border-box;\">\n<section class=\"\" style=\"padding: 10px;box-sizing: border-box;\">\n<section class=\"\" style=\"text-align: center;color: rgb(249, 110, 87);box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\"><span style=\"box-sizing: border-box;background-color: rgb(255, 202, 0);\"><strong style=\"box-sizing: border-box;\">\u70b9\u51fb\u2191<span style=\"color: rgb(95, 156, 239);font-size: 18px;box-sizing: border-box;background-color: rgb(254, 202, 0);\">\u836f\u7814\u6280\u672f\u6c47<\/span>\u5728\u7ebf\u5173\u6ce8<\/strong><br style=\"box-sizing: border-box;\"  \/><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"\" style=\"padding-right: 5px;display: inline-block;vertical-align: top;width: 124.313px;box-sizing: border-box;\">\n<section class=\"Powered-by-XIUMI V5\"  style=\"box-sizing: border-box;\">\n<section class=\"\" style=\"margin-top: 10px;margin-bottom: 10px;box-sizing: border-box;\">\n<section class=\"\" style=\"max-width: 100%;vertical-align: middle;display: inline-block;width: 97.8281px;box-sizing: border-box;overflow: hidden !important;\"><img    width=\"100%\"  style=\"vertical-align: middle;width: 97.8281px;box-sizing: border-box;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/09\/1-1538272378.gif\" alt=\"\u3010FDA\u3011FDA2018\u5e74483\u62a5\u544a\u4e0e\u8b66\u544a\u4fe1\u6c47\u603b\u7bc7\uff1a\u6570\u636e\u53ef\u9760\u6027\u7f3a\u9677\" title=\"\u3010FDA\u3011FDA2018\u5e74483\u62a5\u544a\u4e0e\u8b66\u544a\u4fe1\u6c47\u603b\u7bc7\uff1a\u6570\u636e\u53ef\u9760\u6027\u7f3a\u9677\"  \/><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e8f\u53f7\uff1a<\/span>1<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u5173\u952e\u8bcd\uff1a\u6570\u636e\u53ef\u9760\u6027\uff0c\u6279\u8bb0\u5f55<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u6765\u6e90\uff1a<\/span>FDA\u8b66\u544a\u4fe1<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u53d1\u5e03\u65e5\u671f\uff1a<\/span>20180409<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f01\u4e1a\u540d\u79f0\uff1a\u82f1\u56fd<\/span>McCallum Manufacturing Ltd.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u9879\u63cf\u8ff0\uff1a<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Your firm failed to prepare batch production and control records with &nbsp;complete information relating to the production and control of each batch of &nbsp;drug product produced (21 CFR211.188).<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f60\u516c\u53f8\u672a\u5236\u8ba2\u6279\u751f\u4ea7\u548c\u68c0\u9a8c\u8bb0\u5f55\uff0c\u6765\u8bb0\u5f55\u6240\u751f\u4ea7\u7684\u6bcf\u6279\u836f\u54c1\u7684\u5b8c\u6574\u751f\u4ea7\u548c\u68c0\u9a8c\u4fe1\u606f<\/span>(21 CFR 211.188)\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Your production and control records did not define and document process &nbsp;parameters to ensure that in-process materials and your finished drug products &nbsp;meet quality requirements. For instance, your batch records did not include &nbsp;information such as identity of the equipment, actual (b)(4)time, temperature, &nbsp;filling and packaging operation steps, and yield percentage specifications.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f60\u4eec\u7684\u751f\u4ea7\u548c\u68c0\u6d4b\u8bb0\u5f55\u672a\u5b9a\u4e49\u5e76\u8bb0\u5f55\u5de5\u827a\u53c2\u6570\uff0c\u4ee5\u786e\u4fdd\u4e2d\u95f4\u4f53\u548c\u6210\u54c1\u7b26\u5408\u8d28\u91cf\u8981\u6c42\u3002\u4f8b\u5982\uff0c\u4f60\u4eec\u7684\u6279\u8bb0\u5f55\u5e76\u672a\u5305\u62ec\u5982\u8bbe\u5907\u8bc6\u522b\u4fe1\u606f\u3001\u5b9e\u9645<\/span>XX\u65f6\u957f\u3001\u6e29\u5ea6\u3001\u704c\u88c5\u548c\u5305\u88c5\u64cd\u4f5c\u6b65\u9aa4\u4ee5\u53ca\u6536\u7387\u767e\u5206\u6bd4\u6807\u51c6\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 27px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5e8f\u53f7\uff1a<\/span>2<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u9879\u5173\u952e\u8bcd\uff1a\u6570\u636e\u53ef\u9760\u6027\uff0c\u68c0\u6d4b\u6570\u636e<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u6765\u6e90\uff1a<\/span>FDA\u8b66\u544a\u4fe1<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u53d1\u5e03\u65e5\u671f\uff1a<\/span>20180315<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f01\u4e1a\u540d\u79f0\uff1a\u5370\u5ea6<\/span>Keshava Organics Pvt. Ltd<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u9879\u63cf\u8ff0\uff1a<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Failure to maintain complete laboratory control records for test &nbsp;methods.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u672a\u80fd\u4fdd\u5b58\u5b8c\u6574\u7684\u5b9e\u9a8c\u5ba4\u68c0\u9a8c\u65b9\u6cd5\u8bb0\u5f55\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">In several instances, you failed to maintain complete data for API tested &nbsp;and distributed to the U.S. For example, we found test data sheets with missing &nbsp;sample weights for identity testing, batch\/lot numbers for reference standards &nbsp;and reagents, equipment identification, and complete thin layer chromatography &nbsp;data for related compounds.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5728\u6570\u4e2a\u4e8b\u4f8b\u4e2d\uff0c\u4f60\u4eec\u672a\u80fd\u4fdd\u5b58\u9500\u5f80\u7f8e\u56fd\u7684<\/span>API\u7684\u5b8c\u6574\u68c0\u6d4b\u6570\u636e\u3002\u4f8b\u5982\uff0c\u6211\u4eec\u53d1\u73b0\u68c0\u9a8c\u6570\u636e\u8868\u7f3a\u5931\u4e86\u9274\u522b\u6d4b\u8bd5\u4e2d\u7684\u6837\u54c1\u91cd\u91cf\u3001\u5bf9\u7167\u54c1\u548c\u8bd5\u5242\u7684\u6279\u53f7\u3001\u4eea\u5668\u7f16\u53f7\uff0c\u6709\u5173\u7269\u8d28\u7684\u5b8c\u6574TLC\u6570\u636e\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 27px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5e8f\u53f7\uff1a<\/span>3<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u5173\u952e\u8bcd\uff1a\u6570\u636e\u53ef\u9760\u6027\uff0c\u68c0\u6d4b\u8bb0\u5f55<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u6765\u6e90\uff1a<\/span>FDA\u8b66\u544a\u4fe1<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u53d1\u5e03\u65e5\u671f\uff1a<\/span>20180309<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f01\u4e1a\u540d\u79f0\uff1a\u7c73\u5c3c\u52a0<\/span>Labocont Industrial SRL 20180309<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u578b\u9879\u63cf\u8ff0\uff1a<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Your firm failed to ensure that laboratory records included complete data &nbsp;derived from all tests necessary to assure compliance with established &nbsp;specifications and standards (21 CFR 211.194(a)).<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f60\u4eec\u516c\u53f8\u672a\u80fd\u786e\u4fdd\u5b9e\u9a8c\u5ba4\u8bb0\u5f55\u5305\u62ec\u4e3a\u786e\u4fdd\u7b26\u5408\u65e2\u5b9a\u8d28\u91cf\u6807\u51c6\u6240\u5fc5\u987b\u7684\u6240\u6709\u68c0\u6d4b\u9879\u7684\u5b8c\u6574\u6570\u636e<\/span>(21 CFR211.194(a))\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Your firm does not ensure that complete data from assay testing of your &nbsp;finished drug products and active pharmaceutical ingredients (API) are &nbsp;maintained and reviewed by your quality unit. For example, our investigator &nbsp;observed that an analyst failed to document absorbance data generated during &nbsp;assay analysis, and only reported calculated results.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f60\u516c\u53f8\u672a\u80fd\u786e\u4fdd\u5236\u5242\u4ea7\u54c1\u548c<\/span>API\u542b\u91cf\u7684\u5b8c\u6574\u68c0\u6d4b\u6570\u636e\u7531\u4f60\u4eec\u8d28\u91cf\u90e8\u95e8\u8fdb\u884c\u4fdd\u5b58\u548c\u5ba1\u6838\u3002\u4f8b\u5982\uff0c\u6211\u4eec\u8c03\u67e5\u4eba\u5458\u53d1\u73b0\u4e00\u4f4d\u5206\u6790\u5458\u672a\u8bb0\u5f55\u542b\u91cf\u5206\u6790\u4e2d\u751f\u6210\u7684\u5438\u6536\u6570\u636e\uff0c\u4ec5\u62a5\u544a\u4e86\u8ba1\u7b97\u7ed3\u679c\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Because you do not document and maintain complete data from your analyses, &nbsp;it is not possible to evaluate whether the method was followed and data is &nbsp;valid, or to substantively investigate sources of deviations and variation in &nbsp;your laboratory. It is essential that all data generated during analysis is &nbsp;maintained and reviewed to determine whether laboratory procedures are followed, &nbsp;and raw materials and drug products conform to established specifications.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7531\u4e8e\u4f60\u4eec\u5e76\u672a\u8bb0\u5f55\u548c\u4fdd\u5b58\u6765\u81ea\u5206\u6790\u7684\u5b8c\u6574\u6570\u636e\uff0c\u56e0\u6b64\u65e0\u6cd5\u8bc4\u4f30\u662f\u5426\u9075\u5faa\u68c0\u6d4b\u65b9\u6cd5\u4ee5\u53ca\u6570\u636e\u662f\u5426\u6709\u6548\uff0c\u4e5f\u65e0\u6cd5\u5bf9\u4f60\u4eec\u5b9e\u9a8c\u5ba4\u5185\u7684\u504f\u5dee\u548c\u6ce2\u52a8\u6765\u6e90\u8fdb\u884c\u5b9e\u8d28\u6027\u8c03\u67e5\u3002\u4fdd\u5b58\u5206\u6790\u4e2d\u6240\u751f\u6210\u7684\u6240\u6709\u6570\u636e\u5e76\u8fdb\u884c\u5ba1\u6838\u5bf9\u786e\u5b9a\u662f\u5426\u9075\u5faa\u4e86\u5b9e\u9a8c\u5ba4\u5ba4\u7a0b\u5e8f\uff0c\u786e\u5b9a\u539f\u6599\u548c\u836f\u54c1\u662f\u5426\u7b26\u5408\u65e2\u5b9a\u8d28\u91cf\u6807\u51c6\u662f\u5f88\u91cd\u8981\u7684\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 27px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5e8f\u53f7\uff1a<\/span>4<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u5173\u952e\u8bcd\uff1a\u6570\u636e\u53ef\u9760\u6027\uff0c\u68c0\u6d4b\u6570\u636e<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u6765\u6e90\uff1a<\/span>FDA\u8b66\u544a\u4fe1<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u53d1\u5e03\u65e5\u671f\uff1a<\/span>20180223<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f01\u4e1a\u540d\u79f0\uff1a\u4e2d\u56fd\u6d59\u6c5f\u7eff\u5c9b\u79d1\u6280<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u9879\u63cf\u8ff0\uff1a<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Your firm failed to ensure that laboratory records included complete data &nbsp;derived from all tests necessary to assure compliance with established &nbsp;specifications and standards (21 CFR 211.194(a)).<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f60\u4eec\u516c\u53f8\u672a\u80fd\u786e\u4fdd\u5b9e\u9a8c\u5ba4\u8bb0\u5f55\u5305\u62ec\u4e3a\u786e\u4fdd\u7b26\u5408\u65e2\u5b9a\u8d28\u91cf\u6807\u51c6\u6240\u5fc5\u987b\u7684\u6240\u6709\u68c0\u6d4b\u9879\u7684\u5b8c\u6574\u6570\u636e<\/span>(21 CFR211.194(a))\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Your firm lacks basic laboratory controls to prevent changes to paper and &nbsp;electronic records for your over-the-counter (OTC) drug products. You were not &nbsp;able to provide analytical test data for three batches of (b)(4) spray and one &nbsp;batch of (b)(4).We found that you created certificates of analysis (COA) for &nbsp;these four batches before they were manufactured and tested.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f60\u4eec\u516c\u53f8\u7f3a\u4e4f\u57fa\u672c\u7684\u5b9e\u9a8c\u5ba4\u63a7\u5236\u6765\u9632\u6b62\u5bf9<\/span>OTC\u836f\u54c1\u7eb8\u8d28\u548c\u7535\u5b50\u8bb0\u5f55\u8fdb\u884c\u4fee\u6539\u3002\u4f60\u4eec\u65e0\u6cd5\u63d0\u4f9b3\u6279XX\u55b7\u96fe\u5242\u548c1\u6279XX\u7684\u5206\u6790\u68c0\u6d4b\u6570\u636e\u3002\u6211\u4eec\u53d1\u73b0\u4f60\u4eec\u5728\u8fd94\u6279\u836f\u54c1\u751f\u4ea7\u548c\u68c0\u6d4b\u4e4b\u524d\u5c31\u7f16\u5236\u4e86\u5b83\u4eec\u7684COA\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">When questioned, your firm acknowledged falsifying the analytical test &nbsp;results on the COA you used to support release and distribution of (b)(4) spray &nbsp;and (b)(4) drug products to the United States.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5728\u95ee\u5230\u4f60\u4eec\u65f6\uff0c\u4f60\u4eec\u516c\u53f8\u544a\u77e5\u6211\u4eec\u4f60\u4eec\u634f\u9020\u4e86\u7528\u4ee5\u652f\u6301\u653e\u884c\u548c\u9500\u552e\u81f3\u7f8e\u56fd<\/span>XX\u55b7\u96fe\u5242\u548cXX\u836f\u54c1\u7684COA\u4e0a\u7684\u5206\u6790\u68c0\u6d4b\u7ed3\u679c\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">In addition, we found three electronic data files in the electronic recycle &nbsp;bin of the stand-alone HPLC system you used to test finished drug product (b)(4) &nbsp;spray. Because this instrument lacks back-up and audit trail capabilities, we &nbsp;could not determine how frequently test data obtained prior to \u201cofficial\u201d batch &nbsp;testing was discarded. You were unable to explain why these electronic files &nbsp;were deleted.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u6b64\u5916\uff0c\u6211\u4eec\u5728\u4f60\u4eec\u7528\u4ee5\u68c0\u6d4b\u6210\u54c1<\/span>XX\u55b7\u96fe\u5242\u7684\u5355\u673a\u7248HPLC\u7cfb\u7edf\u7684\u7535\u5b50\u56de\u6536\u7ad9\u53d1\u73b03\u4e2a\u7535\u5b50\u6570\u636e\u6587\u4ef6\u3002\u7531\u4e8e\u6b64\u4eea\u5668\u7f3a\u4e4f\u5907\u4efd\u548c\u5ba1\u8ba1\u8ffd\u8e2a\u80fd\u529b\uff0c\u6211\u4eec\u65e0\u6cd5\u786e\u5b9a\u4f60\u4eec\u5728\u201c\u6b63\u5f0f\u201d\u6279\u68c0\u6d4b\u4e4b\u524d\u5f03\u9664\u4e86\u591a\u5c11\u6b21\u7684\u68c0\u6d4b\u6570\u636e\u3002\u4f60\u4eec\u65e0\u6cd5\u89e3\u91ca\u4e3a\u4ec0\u4e48\u8981\u5220\u9664\u8fd9\u4e9b\u7535\u5b50\u6587\u4ef6\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">cGMP-related data must be retained by a laboratory to enable appropriate &nbsp;assessments and decisions by the quality unit regarding batch disposition and to &nbsp;demonstrate ongoing control.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5b9e\u9a8c\u5ba4\u5fc5\u987b\u4fdd\u5b58<\/span>cGMP\u76f8\u5173\u7684\u6570\u636e\uff0c\u4f9b\u8d28\u91cf\u90e8\u95e8\u8fdb\u884c\u9002\u5f53\u7684\u8bc4\u4f30\u548c\u6279\u5904\u7406\u51b3\u5b9a\u5e76\u4fdd\u8bc1\u5176\u6301\u7eed\u53d7\u63a7\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 27px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5e8f\u53f7\uff1a<\/span>5<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u5173\u952e\u8bcd\uff1a\u6570\u636e\u53ef\u9760\u6027\uff0c\u4f2a\u9020\u5b9e\u9a8c\u5ba4\u6570\u636e<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u6765\u6e90\uff1a<\/span>FDA\u8b66\u544a\u4fe1<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u53d1\u5e03\u65e5\u671f\uff1a<\/span>20180216<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f01\u4e1a\u540d\u79f0\uff1a\u5370\u5ea6<\/span>Alchymars ICM SM Private Limited<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u9879\u63cf\u8ff0\uff1a<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Failure to have laboratory control records that include complete data &nbsp;derived from all laboratory tests conducted to ensure your API complies with &nbsp;established specifications and standards.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u6ca1\u6709\u5b9e\u9a8c\u5ba4\u68c0\u6d4b\u8bb0\u5f55\uff0c\u5176\u4e2d\u5305\u62ec\u4e3a\u786e\u4fdd\u4f60\u4eec<\/span>API\u7b26\u5408\u65e2\u5b9a\u8d28\u91cf\u6807\u51c6\u6240\u5b9e\u65bd\u7684\u6240\u6709\u5b9e\u9a8c\u5ba4\u6d4b\u8bd5\u6240\u751f\u6210\u7684\u5b8c\u6574\u6570\u636e\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Our investigator found that your firm was falsifying laboratory data. For &nbsp;example, the number of colony-forming units (CFU) found on (b)(4) plates for &nbsp;(b)(4)water point-of-use tests differed substantially from the number recorded &nbsp;on your (b)(4) water report. For multiple points of use, your analyst reported &nbsp;far fewer CFU than observed on the plate by our investigator. In addition, while &nbsp;you reported absence of growth on a selective media plate used to detect &nbsp;objectionable microorganisms, our investigator observed growth on this plate. &nbsp;This is concerning because you use(b)(4) water to manufacture products, such as &nbsp;(b)(4) API, that are intended for use in sterile injectable dosage forms.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u6211\u4eec\u7684\u8c03\u67e5\u4eba\u5458\u53d1\u73b0\u4f60\u4eec\u516c\u53f8\u4f2a\u9020\u5b9e\u9a8c\u5ba4\u6570\u636e\u3002\u4f8b\u5982\uff0c\u5728<\/span>XX\u7528\u6c34\u70b9\u68c0\u6d4bXX\u789f\u4e0a\u53d1\u73b0\u7684\u83cc\u843d\u5f62\u6210\u5355\u4f4d(CFU)\u6570\u91cf\u4e0e\u4f60\u4eec\u7684XX\u6c34\u62a5\u544a\u4e0a\u6240\u8bb0\u5f55\u7684\u6570\u503c\u6709\u663e\u8457\u5dee\u5f02\u3002\u6709\u591a\u4e2a\u4f7f\u7528\u70b9\uff0c\u4f60\u4eec\u5206\u6790\u5458\u6240\u62a5\u544a\u7684\u6570\u503c\u90fd\u8fdc\u4f4e\u4e8e\u6211\u4eec\u8c03\u67e5\u4eba\u5458\u5728\u4f60\u4eec\u789f\u4e0a\u770b\u5230\u7684\u3002\u53e6\u5916\uff0c\u867d\u7136\u4f60\u4eec\u62a5\u544a\u8bf4\u5728\u4e00\u4e2a\u7528\u4e8e\u68c0\u51fa\u81f4\u75c5\u83cc\u7684\u9009\u62e9\u6027\u57f9\u517b\u57fa\u789f\u4e0a\u672a\u68c0\u51fa\u5fae\u751f\u7269\u751f\u957f\uff0c\u4f46\u6211\u4eec\u8c03\u67e5\u4eba\u5458\u5374\u5728\u8be5\u789f\u4e0a\u770b\u5230\u4e86\u5fae\u751f\u7269\u751f\u957f\u3002\u8fd9\u79cd\u60c5\u51b5\u4ee4\u4eba\u62c5\u5fe7\uff0c\u56e0\u4e3a\u4f60\u4eec\u4f7f\u7528XX\u6c34\u7528\u4e8e\u4f8b\u5982XX\u539f\u6599\u836f\u7684\u751f\u4ea7\uff0c\u8be5\u539f\u6599\u836f\u53c8\u5c06\u7528\u4e8e\u65e0\u83cc\u6ce8\u5c04\u5236\u5242\u836f\u54c1\u7684\u751f\u4ea7\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 27px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5e8f\u53f7\uff1a<\/span>6<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u5173\u952e\u8bcd\uff1a\u6570\u636e\u53ef\u9760\u6027\uff0c\u8bbe\u5907\u7ef4\u62a4\u8bb0\u5f55<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u6765\u6e90\uff1a<\/span>FDA\u8b66\u544a\u4fe1<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u53d1\u5e03\u65e5\u671f\uff1a<\/span>20180216<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f01\u4e1a\u540d\u79f0\uff1a\u5370\u5ea6<\/span>Alchymars ICM SM Private Limited<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u9879\u63cf\u8ff0\uff1a<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Failure to properly maintain equipment and to keep complete records of &nbsp;major equipment maintenance.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u672a\u80fd\u5bf9\u8bbe\u5907\u8fdb\u884c\u59a5\u5584\u7ef4\u62a4\uff0c\u5e76\u4fdd\u5b58\u4e3b\u8981\u8bbe\u5907\u7ef4\u62a4\u7684\u5b8c\u6574\u8bb0\u5f55\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Our investigator found damaged product-contact surfaces on your &nbsp;multi-product equipment. For example, the man hole gasket of (b)(4)111 was &nbsp;deteriorating and wrapped in peeling tape. A gasket on the (b)(4)102 was also &nbsp;cracked in one area and wrapped in peeling tape.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u6211\u4eec\u8c03\u67e5\u4eba\u5458\u53d1\u73b0\u4f60\u4eec\u591a\u4ea7\u54c1\u751f\u4ea7\u8bbe\u5907\u4e0e\u4ea7\u54c1\u63a5\u89e6\u7684\u8868\u9762\u53d7\u635f\u3002\u4f8b\u5982\uff0c<\/span>XX111\u7684\u4eba\u5b54\u57ab\u5708\u635f\u574f\uff0c\u5305\u88f9\u5728\u5265\u843d\u7684\u80f6\u5e26\u4e2d\u3002XX102\u7684\u57ab\u5708\u4e5f\u6709\u4e00\u4e2a\u5730\u65b9\u88c2\u5f00\u4e86\uff0c\u4e5f\u662f\u5305\u88f9\u5728\u5265\u843d\u7684\u80f6\u5e26\u4e2d\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Your SOP\/ENG\/39-1, Gasket Management for Equipments and Pipelines which are &nbsp;in Direct Contact with the Product, section 4.18, requires you to replace &nbsp;gaskets in critical areas, including gaskets for (b)(4)111 and (b)(4)102, &nbsp;(b)(4).Your firm was unable to provide gasket replacement records for this &nbsp;equipment during the inspection.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f60\u4eec\u7684<\/span>SOP\/ENG\/39-1\u201c\u4e0e\u4ea7\u54c1\u76f4\u63a5\u63a5\u89e6\u7684\u8bbe\u5907\u548c\u7ba1\u9053\u57ab\u5708\u7ba1\u7406\u201d\u7b2c4.18\u90e8\u5206\u8981\u6c42\u4f60\u4eec\u5bf9\u5173\u952e\u533a\u57df\u7684\u57ab\u5708\u8fdb\u884c\u66f4\u6362\uff0c\u5305\u62ecXX111\u548cXX102\u7684\u57ab\u5708\u3002\u4f60\u4eec\u516c\u53f8\u5728\u68c0\u67e5\u671f\u95f4\u672a\u80fd\u63d0\u4f9b\u8be5\u8bbe\u5907\u7684\u57ab\u5708\u66f4\u6362\u8bb0\u5f55\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Furthermore, the most recent records of your firm checking the condition of &nbsp;the gaskets for (b)(4)102were from January 2017, more than (b)(4) before our &nbsp;inspection.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u8fd8\u6709\uff0c\u4f60\u4eec\u516c\u53f8\u68c0\u67e5<\/span>XX102\u57ab\u5708\u60c5\u51b5\u7684\u6700\u8fd1\u8bb0\u5f55\u662f\u4ece2017\u5e741\u6708\u5f00\u59cb\u7684\uff0c\u5728\u6211\u4eec\u68c0\u67e5\u4e4b\u524dXX\u65f6\u957f\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">This is a repeat observation from our February 2015 inspection. We also &nbsp;note that you have found deteriorating gaskets to be the root cause for finished &nbsp;API particle complaints.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u8fd9\u662f<\/span>2015\u5e742\u6708\u6211\u4eec\u68c0\u67e5\u4e2d\u53d1\u73b0\u7684\u91cd\u590d\u7f3a\u9677\u3002\u6211\u4eec\u4e5f\u6ce8\u610f\u5230\u4f60\u4eec\u5df2\u53d1\u73b0\u4e86\u8001\u5316\u7684\u57ab\u5708\u662f\u6210\u54c1\u539f\u6599\u836f\u9897\u7c92\u7269\u6295\u8bc9\u7684\u6839\u672c\u539f\u56e0\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Your response is inadequate. You stated that the \u201cinvolved gasket was &nbsp;immediately substituted\u201d but did not evaluate all other gaskets on your &nbsp;manufacturing equipment. You indicated that you will update your procedure to &nbsp;require a supervisor walk-through to assess product contact surfaces, but did &nbsp;not include sufficient detail (e.g. frequency of equipment inspection). You also &nbsp;failed to address the lack of gasket maintenance records.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f60\u4eec\u7684\u56de\u590d\u662f\u4e0d\u5145\u5206\u7684\u3002\u4f60\u4eec\u58f0\u79f0<\/span>\u201c\u6240\u6d89\u53ca\u7684\u57ab\u5708\u9a6c\u4e0a\u5c31\u88ab\u66ff\u6362\u4e86\u201d\uff0c\u4f46\u5e76\u672a\u8bc4\u4f30\u4f60\u4eec\u751f\u4ea7\u8bbe\u5907\u4e0a\u6240\u6709\u5176\u5b83\u57ab\u5708\u3002\u4f60\u4eec\u8bf4\u4f60\u4eec\u4f1a\u66f4\u65b0\u4f60\u4eec\u7684\u7a0b\u5e8f\uff0c\u8981\u6c42\u4e3b\u7ba1\u73b0\u573a\u6392\u67e5\u4ee5\u8bc4\u4f30\u4ea7\u54c1\u63a5\u89e6\u8868\u9762\uff0c\u4f46\u5e76\u672a\u5305\u62ec\u8db3\u591f\u8be6\u7ec6\u7684\u5185\u5bb9(\u4f8b\u5982\uff0c\u8bbe\u5907\u68c0\u67e5\u7684\u9891\u6b21)\u3002\u4f60\u4eec\u4e5f\u672a\u89e3\u51b3\u7f3a\u5c11\u57ab\u5708\u7ef4\u62a4\u8bb0\u5f55\u7684\u95ee\u9898\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 27px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5e8f\u53f7\uff1a<\/span>7<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u5173\u952e\u8bcd\uff1a\u6570\u636e\u53ef\u9760\u6027\uff0c\u4f2a\u9020\u5b9e\u9a8c\u5ba4\u68c0\u6d4b\u6570\u636e<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u6765\u6e90\uff1a<\/span>FDA\u8b66\u544a\u4fe1<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u53d1\u5e03\u65e5\u671f\uff1a<\/span>20180202<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f01\u4e1a\u540d\u79f0\uff1a\u97e9\u56fd<\/span>Cosmecca Korea Co., Ltd.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u9879\u63cf\u8ff0\uff1a<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Your firm failed to ensure that laboratory records included complete data &nbsp;derived from all tests necessary to assure compliance with established &nbsp;specifications and standards (21 CFR 211.194(a)).<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f60\u4eec\u516c\u53f8\u672a\u80fd\u786e\u4fdd\u5b9e\u9a8c\u5ba4\u8bb0\u5f55\u5305\u62ec\u4e3a\u786e\u4fdd\u7b26\u5408\u65e2\u5b9a\u8d28\u91cf\u6807\u51c6\u6240\u5fc5\u987b\u7684\u6240\u6709\u68c0\u6d4b\u9879\u7684\u5b8c\u6574\u6570\u636e<\/span>(21 CFR211.194(a))\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Our investigator documented multiple examples of falsifying laboratory &nbsp;records. Your quality control laboratory employee stated that he fabricated &nbsp;laboratory data for untested finished drug products by manipulating electronic &nbsp;laboratory records. For example, he changed the file names for test results of &nbsp;previously tested drugs so that the file names appeared to reflect the results &nbsp;of other lots of product. Your firm used this falsified laboratory data to &nbsp;determine the strength of your OTC (b)(4) drug products. Your response stated &nbsp;that your quality assurance manager instructed laboratory analysts to &nbsp;manipulate, falsify, or fabricate data.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u6211\u4eec\u7684\u8c03\u67e5\u4eba\u5458\u8bb0\u5f55\u4e0b\u4e86\u591a\u4e2a\u4f2a\u9020\u5b9e\u9a8c\u5ba4\u8bb0\u5f55\u7684\u4f8b\u5b50\u3002\u4f60\u4eec\u7684<\/span>QC\u5b9e\u9a8c\u5ba4\u5458\u5de5\u8bf4\u4ed6\u901a\u8fc7\u634f\u9020\u7535\u5b50\u5b9e\u9a8c\u8bb0\u5f55\u4e3a\u672a\u68c0\u6d4b\u7684\u836f\u54c1\u4f2a\u9020\u5b9e\u9a8c\u5ba4\u6570\u636e\u3002\u4f8b\u5982\uff0c\u4ed6\u66f4\u6539\u4e86\u4e4b\u524d\u68c0\u6d4b\u836f\u54c1\u7684\u68c0\u6d4b\u7ed3\u679c\u7684\u6587\u4ef6\u540d\uff0c\u8fd9\u6837\u8be5\u6587\u4ef6\u540d\u770b\u8d77\u6765\u53cd\u6620\u7684\u662f\u53e6\u4e00\u4e9b\u6279\u6b21\u836f\u54c1\u7684\u68c0\u6d4b\u7ed3\u679c\u3002\u4f60\u4eec\u516c\u53f8\u4f7f\u7528\u8fd9\u4e9b\u4f2a\u9020\u7684\u5b9e\u9a8c\u5ba4\u6570\u636e\u6765\u51b3\u5b9a\u4f60\u4eecOTC &nbsp;XX\u836f\u54c1\u7684\u5242\u91cf\u3002\u4f60\u4eec\u5728\u56de\u590d\u4e2d\u58f0\u79f0\u8bf4\u4f60\u4eec\u7684QA\u7ecf\u7406\u6307\u793a\u5206\u6790\u5458\u634f\u9020\u3001\u4f2a\u9020\u6216\u865a\u6784\u6570\u636e\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 27px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5e8f\u53f7\uff1a<\/span>8<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u5173\u952e\u8bcd\uff1a\u6570\u636e\u53ef\u9760\u6027\uff0c\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\uff0c\u6743\u9650\u63a7\u5236<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u6765\u6e90\uff1a<\/span>FDA\u8b66\u544a\u4fe1<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u53d1\u5e03\u65e5\u671f\uff1a<\/span>20180202<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f01\u4e1a\u540d\u79f0\uff1a\u97e9\u56fd<\/span>Cosmecca Korea Co., Ltd.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u9879\u63cf\u8ff0\uff1a<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Your firm failed to exercise appropriate controls over computer or related &nbsp;systems to assure that only authorized personnel institute changes in master &nbsp;production and control records, or other records (21 CFR 211.68(b)).<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f60\u516c\u53f8\u672a\u80fd\u5bf9\u8ba1\u7b97\u673a\u548c\u76f8\u5173\u7cfb\u7edf\u6267\u884c\u9002\u5f53\u7684\u63a7\u5236\u4ee5\u786e\u4fdd\u53ea\u6709\u7ecf\u8fc7\u6388\u6743\u7684\u4eba\u5458\u624d\u53ef\u4ee5\u4fee\u6539\u4e3b\u751f\u4ea7\u548c\u68c0\u6d4b\u8bb0\u5f55\u4ee5\u53ca\u5176\u5b83\u8bb0\u5f55<\/span>(21 CFR211.68(b))\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Laboratory equipment used to generate analytical data for release purposes &nbsp;lacked restricted access. For example, analysts shared usernames and passwords, &nbsp;and all users had administrator rights that permitted them to delete or modify &nbsp;files in high-performance liquid chromatography and gas chromatography &nbsp;equipment. You had no mechanism to facilitate traceability of the individuals &nbsp;who changed, adjusted, or modified data generated by computerized systems.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7528\u4e8e\u751f\u6210\u653e\u884c\u6240\u9700\u7684\u5206\u6790\u6570\u636e\u7684\u5b9e\u9a8c\u5ba4\u8bbe\u5907\u7f3a\u4e4f\u6743\u9650\u63a7\u5236\u3002\u4f8b\u5982\uff0c\u5b9e\u9a8c\u5ba4\u5171\u7528\u7528\u6237\u540d\u548c\u5bc6\u7801\uff0c\u6240\u6709\u7528\u6237\u90fd\u5177\u6709\u7ba1\u7406\u5458\u6743\u9650\uff0c\u5747\u53ef\u4ee5\u5220\u9664\u6216\u4fee\u6539<\/span>HPLC\u548cGC\u4eea\u5668\u4e2d\u7684\u6587\u4ef6\u3002\u4f60\u4eec\u6ca1\u6709\u673a\u5236\u6765\u5ba1\u8ba1\u8ddf\u8e2a\u4f55\u4eba\u4fee\u6539\u3001\u8c03\u6574\u6216\u6539\u52a8\u4e86\u8ba1\u7b97\u5316\u7cfb\u7edf\u751f\u6210\u7684\u6570\u636e\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5e8f\u53f7\uff1a<\/span>9<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u5173\u952e\u8bcd\uff1a\u6570\u636e\u53ef\u9760\u6027<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u6765\u6e90\uff1a<\/span>FDA\u8b66\u544a\u4fe1<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u53d1\u5e03\u65e5\u671f\uff1a<\/span>20180202<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f01\u4e1a\u540d\u79f0\uff1a\u97e9\u56fd<\/span>Cosmecca Korea Co., Ltd.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u9879\u63cf\u8ff0\uff1a<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Your firm\u2019s quality control unit failed to review and approve all drug &nbsp;product production and control records to determine compliance with all &nbsp;established, approved written procedures before a batch is released or &nbsp;distributed (21 CFR 211.192).<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f60\u4eec\u516c\u53f8\u7684\u8d28\u91cf\u63a7\u5236\u90e8\u95e8\u672a\u80fd\u5ba1\u6838\u548c\u6279\u51c6\u6240\u6709\u836f\u54c1\u751f\u4ea7\u548c\u68c0\u6d4b\u8bb0\u5f55\u6765\u786e\u5b9a\u4ea7\u54c1\u5728\u653e\u884c\u6216\u9500\u552e\u4e4b\u524d\u662f\u5426\u7b26\u5408\u6240\u6709\u65e2\u5b9a\u7684\u5df2\u6279\u51c6\u7684\u4e66\u9762\u7a0b\u5e8f<\/span>(21 CFR &nbsp;211.192)\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Your OTC sunscreen drug product, (b)(4), contains (b)(4) active &nbsp;ingredients: (b)(4).Your batch records for lot (b)(4)of this product included &nbsp;concentration values for these active ingredients that did not match the data &nbsp;found in your instruments. You used the inaccurate data reported in your batch &nbsp;records to calculate potency results that were within specification, and you &nbsp;relied on these inaccurate results to release your product. However, when we &nbsp;used the instrument data instead of the results in your batch records to perform &nbsp;the same calculations, we found that the lot was out-of-specification &nbsp;(OOS)(super potent) for (b)(4) active ingredients. Your quality unit did not &nbsp;identify this discrepancy prior to releasing this lot.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f60\u4eec\u7684<\/span>OTC\u9632\u6652\u836f\u54c1XX\u4e2d\u542b\u6709XX\u6d3b\u6027\u6210\u5206\uff1aXX\u3002\u4f60\u4eecXX\u6279\u6b21\u7684\u8be5\u836f\u54c1\u7684\u6279\u8bb0\u5f55\u5305\u62ec\u6709\u8fd9\u4e9b\u6d3b\u6027\u6210\u5206\u7684\u6d53\u5ea6\u503c\uff0c\u4e0e\u5728\u4f60\u4eec\u4eea\u5668\u4e2d\u53d1\u73b0\u7684\u6570\u636e\u5e76\u4e0d\u76f8\u7b26\u3002\u4f60\u4eec\u4f7f\u7528\u4e86\u4e0d\u51c6\u786e\u7684\u6570\u636e\u62a5\u544a\u5728\u4f60\u4eec\u7684\u6279\u8bb0\u5f55\u4e2d\u7528\u4ee5\u8ba1\u7b97\u5f97\u5230\u7b26\u5408\u8d28\u91cf\u6807\u51c6\u7684\u542b\u91cf\u7ed3\u679c\uff0c\u4f60\u4eec\u4f9d\u8d56\u8fd9\u4e9b\u4e0d\u51c6\u786e\u7684\u7ed3\u679c\u6765\u653e\u884c\u4f60\u4eec\u7684\u4ea7\u54c1\u3002\u4f46\u662f\uff0c\u5f53\u6211\u4eec\u4f7f\u7528\u4eea\u5668\u4e2d\u7684\u6570\u636e\u66ff\u4ee3\u4f60\u4eec\u6279\u8bb0\u5f55\u4e2d\u7684\u6570\u636e\u6765\u8fdb\u884c\u76f8\u540c\u7684\u8ba1\u7b97\u65f6\uff0c\u6211\u4eec\u53d1\u73b0\u8be5\u6279\u6b21\u7684XX\u6d3b\u6027\u6210\u5206\u662fOOS(\u8d85\u8fc7\u6548\u4ef7)\u3002\u4f60\u4eec\u7684\u8d28\u91cf\u90e8\u95e8\u5728\u653e\u884c\u6b64\u6279\u51c6\u65f6\u5e76\u672a\u53d1\u73b0\u6b64\u5206\u6b67\u5904\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 27px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5e8f\u53f7\uff1a<\/span>10<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u5173\u952e\u8bcd\uff1a\u6570\u636e\u53ef\u9760\u6027\uff0c\u634f\u9020<\/span>COA\u6570\u636e<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u6765\u6e90\uff1a<\/span>FDA\u8b66\u544a\u4fe1<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u53d1\u5e03\u65e5\u671f\uff1a<\/span>20180118<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f01\u4e1a\u540d\u79f0\uff1a\u65e5\u672c<\/span>Daito Kasei Kogyo Co., LTD., Okayama Factory<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u9879\u63cf\u8ff0\uff1a<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Failure to completely report test results on certificates of analysis.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u672a\u5728<\/span>COA\u4e0a\u5b8c\u6574\u62a5\u544a\u68c0\u6d4b\u7ed3\u679c<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">During the inspection, were viewed certificates of analysis (COA) for &nbsp;batches of (b)(4) API that you manufactured and released between June 2011 and &nbsp;February 2016. Your quality control unit signed these COA, which indicated that &nbsp;all required tests had been conducted on these batches. However, you told our &nbsp;investigator during the inspection that you signed these COA without having &nbsp;conducted all the tests for which you reported results on these COA. For &nbsp;example, your COA reported the results of identity and impurities tests that you &nbsp;never conducted.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5728\u68c0\u67e5\u671f\u95f4\uff0c\u6211\u4eec\u5ba1\u6838\u4e86\u4f60\u4eec\u5728<\/span>2011\u5e74\u81f32016\u5e742\u6708\u671f\u95f4\u751f\u4ea7\u548c\u653e\u884c\u7684XX\u6279\u6b21API\u7684COA\u3002\u4f60\u4eec\u7684QC\u90e8\u95e8\u7b7e\u7f72\u4e86\u8fd9\u4e9bCOA\uff0c\u8fd9\u8868\u793a\u5bf9\u8fd9\u4e9b\u6279\u6b21\u7684\u6240\u6709\u6240\u9700\u68c0\u6d4b\u5747\u5df2\u6267\u884c\u3002\u4f46\u662f\uff0c\u4f60\u4eec\u5728\u68c0\u67e5\u671f\u95f4\u544a\u8bc9\u6211\u4eec\u8c03\u67e5\u4eba\u5458\u8bf4\u4f60\u4eec\u5e76\u672a\u6267\u884c\u6240\u6709\u68c0\u6d4b\u5c31\u83b7\u5f97\u4e86\u8fd9\u4e9bCOA\u4e0a\u7684\u62a5\u544a\u7ed3\u679c\uff0c\u5e76\u7b7e\u7f72\u4e86\u8fd9\u4e9bCOA\u3002\u4f8b\u5982\uff0c\u4f60\u4eec\u7684COA\u62a5\u544a\u4e86\u9274\u522b\u7ed3\u679c\u548c\u6742\u8d28\u68c0\u6d4b\uff0c\u4f46\u4f60\u4eec\u6839\u672c\u672a\u8fdb\u884c\u68c0\u6d4b\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">You falsified the COA you issued to your customers. Regulators and &nbsp;customers rely on COA for accurate information about the quality and sourcing of &nbsp;drugs and their components. Falsifying information about the quality of your &nbsp;drugs on COA compromises supply chain accountability and traceability, and may &nbsp;put consumers at risk.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f60\u4eec\u634f\u9020\u4e86\u7b7e\u53d1\u7ed9\u5ba2\u6237\u7684<\/span>COA\u3002\u6cd5\u89c4\u76d1\u7ba1\u4eba\u5458\u548c\u5ba2\u6237\u4f9d\u8d56\u4e8eCOA\uff0c\u6765\u786e\u8ba4\u836f\u54c1\u53ca\u5176\u6210\u5206\u7684\u8d28\u91cf\u51c6\u786e\u4fe1\u606f\u548c\u6765\u6e90\u3002\u5728COA\u4e0a\u634f\u9020\u5173\u4e8e\u4f60\u4eec\u836f\u54c1\u7684\u8d28\u91cf\u4fe1\u606f\u4f7f\u5f97\u4f9b\u5e94\u94fe\u53ef\u9760\u6027\u548c\u53ef\u8ffd\u6eaf\u6027\u53d7\u5230\u7834\u574f\uff0c\u53ef\u80fd\u4f1a\u5c06\u6d88\u8d39\u8005\u7f6e\u4e8e\u98ce\u9669\u4e0b\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 27px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5e8f\u53f7\uff1a<\/span>11<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u5173\u952e\u8bcd\uff1a\u6570\u636e\u53ef\u9760\u6027\uff0c\u5386\u53f2\u5206\u6790\u6570\u636e\u4fdd\u5b58<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u6765\u6e90\uff1a<\/span>FDA\u8b66\u544a\u4fe1<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u53d1\u5e03\u65e5\u671f\uff1a<\/span>20180109<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f01\u4e1a\u540d\u79f0\uff1a\u4e2d\u56fd\u6e56\u5357\u65b0\u5408\u65b0<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u9879\u63cf\u8ff0\uff1a<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Failure to maintain complete data derived from all laboratory tests &nbsp;conducted to ensure your API and intermediates comply with established &nbsp;specifications and standards.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u672a\u80fd\u4fdd\u5b58\u6240\u6709\u4e3a\u786e\u4fdd\u4f60\u4eec\u539f\u6599\u836f\u548c\u4e2d\u95f4\u4f53\u7b26\u5408\u65e2\u5b9a\u6807\u51c6\u800c\u6267\u884c\u7684\u5b9e\u9a8c\u5ba4\u68c0\u6d4b\u4e2d\u751f\u6210\u7684\u5b8c\u6574\u6570\u636e\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Your firm failed to retain and locate the analytical raw data for batches &nbsp;(b)(4) and (b)(4) of (b)(4)base which you shipped to the United States in 2014. &nbsp;In your response, you stated the \u201canalytical data was not backed up.\u201d You also &nbsp;said that you transferred the instrument that generated the data to your (b)(4) &nbsp;branch in 2015 and that the staff there deleted the data. It is essential to &nbsp;retain raw data to ensure the ability to reconstruct cGMP activities and review &nbsp;raw data, as necessary, for deviations and investigations.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f60\u4eec\u516c\u53f8\u672a\u4fdd\u5b58\u4f60\u4eec\u5728<\/span>2014\u5e74\u9500\u5f80\u7f8e\u56fd\u7684XX\u57faXX\u6279\u548cXX\u6279\u7684\u5206\u6790\u539f\u59cb\u6570\u636e\u3002\u5728\u4f60\u4eec\u7684\u56de\u590d\u4e2d\uff0c\u4f60\u4eec\u58f0\u79f0\u201c\u5206\u6790\u6570\u636e\u6ca1\u6709\u5907\u4efd\u201d\u3002\u4f60\u4eec\u8fd8\u8bf4\u4f60\u4eec\u5c06\u751f\u6210\u8fd9\u4e9b\u6570\u636e\u7684\u4eea\u5668\u4e8e2015\u5e74\u8f6c\u79fb\u81f3\u4f60\u4eecXX\u5206\u90e8\uff0c\u90a3\u513f\u7684\u5458\u5de5\u5220\u9664\u4e86\u8fd9\u4e9b\u6570\u636e\u3002\u4fdd\u5b58\u539f\u59cb\u6570\u636e\u4ee5\u786e\u4fdd\u53ef\u4ee5\u8fd8\u539fcGMP\u6d3b\u52a8\u548c\u5728\u5fc5\u8981\u65f6\u5982\u504f\u5dee\u53ca\u8c03\u67e5\u65f6\u5bf9\u539f\u59cb\u6570\u636e\u7684\u5ba1\u6838\u662f\u57fa\u672c\u8981\u6c42\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 27px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5e8f\u53f7\uff1a<\/span>12<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u5173\u952e\u8bcd\uff1a\u6570\u636e\u53ef\u9760\u6027\uff0c\u6279\u8bb0\u5f55<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u6765\u6e90\uff1a<\/span>FDA\u8b66\u544a\u4fe1<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u53d1\u5e03\u65e5\u671f\uff1a<\/span>20180109<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f01\u4e1a\u540d\u79f0\uff1a\u4e2d\u56fd\u6e56\u5357\u65b0\u5408\u65b0<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u9879\u63cf\u8ff0\uff1a<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Failure to prepare and use production and control records for each &nbsp;intermediate and API batch.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u672a\u4e3a\u6bcf\u4e2a\u6279\u6b21\u4e2d\u95f4\u4f53\u548c\u539f\u6599\u836f\u5236\u8ba2\u5e76\u4f7f\u7528\u751f\u4ea7\u548c\u68c0\u9a8c\u6279\u8bb0\u5f55\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Your Quality Unit failed to retain and locate 20 of (b)(4) of your (b)(4) &nbsp;base batch records, including but not limited to records for batches (b)(4) and &nbsp;(b)(4).In your response, you stated the batch records \u201care not missing\u201d and are &nbsp;\u201carchived properly.\u201d Your response is inadequate because you did not provide &nbsp;evidence, such as copies of the executed batch records.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f60\u4eec\u8d28\u91cf\u90e8\u95e8\u672a\u80fd\u4fdd\u5b58\u548c\u627e\u5230<\/span>20\u6279\u4f60\u4eec\u7684XX\u6279\u4ea7\u54c1\u7684\u8bb0\u5f55\uff0c\u5305\u62ec\u4f46\u4e0d\u4ec5\u9650\u5730XX\u6279\u548cXX\u6279\u8bb0\u5f55\u3002\u5728\u4f60\u4eec\u7684\u56de\u590d\u4e2d\uff0c\u4f60\u4eec\u58f0\u79f0\u6279\u8bb0\u5f55\u201c\u5e76\u672a\u4e22\u5931\u201d\uff0c\u800c\u662f\u201c\u59a5\u5584\u5f52\u6863\u4fdd\u5b58\u201d\u4e86\u3002\u4f60\u4eec\u7684\u56de\u590d\u662f\u4e0d\u5145\u5206\u7684\uff0c\u56e0\u4e3a\u4f60\u4eec\u672a\u63d0\u4ea4\u8bc1\u636e\uff0c\u5982\u5df2\u6267\u884c\u6279\u8bb0\u5f55\u7684\u526f\u672c\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Additionally, your Quality Assurance department approved batch record &nbsp;0220151203 and batch record0220151204 despite the inaccuracy of the weight of &nbsp;raw materials added. In your response, you stated the operator \u201cdid not follow &nbsp;the procedure\u201d and did not recognize this as a deviation. You also stated &nbsp;personnel had \u201cinadequate awareness of deviations.\u201d It is your responsibility to &nbsp;ensure the accuracy and completeness of your batch records in order to establish &nbsp;that your manufacturing process was followed and is reproducible.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u53e6\u5916\uff0c\u4f60\u4eec\u7684<\/span>QA\u90e8\u5206\u5df2\u6279\u51c6\u4e86\u6279\u8bb0\u5f550220151203\u548c\u6279\u8bb0\u5f550220151204\uff0c\u4f46\u6240\u52a0\u5165\u7684\u539f\u6599\u91cd\u91cf\u662f\u4e0d\u51c6\u786e\u7684\u3002\u5728\u4f60\u4eec\u7684\u56de\u590d\u4e2d\uff0c\u4f60\u4eec\u58f0\u79f0\u64cd\u4f5c\u5de5\u201c\u672a\u9075\u5b88\u7a0b\u5e8f\u201d\uff0c\u5e76\u4e14\u4e0d\u8ba4\u4e3a\u8fd9\u662f\u4e00\u4e2a\u504f\u5dee\u3002\u4f60\u4eec\u8fd8\u58f0\u79f0\u4eba\u5458\u201c\u5bf9\u504f\u5dee\u7684\u4e86\u89e3\u4e0d\u8db3\u201d\u3002\u4f60\u4eec\u6709\u8d23\u4efb\u786e\u4fdd\u4f60\u4eec\u6279\u8bb0\u5f55\u7684\u51c6\u786e\u6027\u548c\u5b8c\u6574\u6027\uff0c\u4ee5\u8bc1\u660e\u4f60\u4eec\u9075\u5b88\u4f60\u4eec\u7684\u751f\u4ea7\u5de5\u827a\uff0c\u5e76\u4e14\u5de5\u827a\u662f\u53ef\u91cd\u590d\u7684\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 27px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5e8f\u53f7\uff1a<\/span>13<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u5173\u952e\u8bcd\uff1a\u6570\u636e\u53ef\u9760\u6027\uff0c\u8bb0\u5f55\u4fdd\u5b58<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u6765\u6e90\uff1a<\/span>FDA 483<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u53d1\u5e03\u65e5\u671f\uff1a<\/span>20180411<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f01\u4e1a\u540d\u79f0\uff1a\u5370\u5ea6<\/span>Alkem Laboratories<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u9879\u63cf\u8ff0\uff1a<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">In addition, your firm failed to maintain and retain logbooks that are not &nbsp;obsolete or outdated. For example, once completed your firm destroys logbooks &nbsp;from the following areas: (b)(4) block warehouse, Housekeeping (b)(4)-Block QC, &nbsp;(b)(4)-Block QA,(b)(4)-Block Manufacturing, (b)(4)-Block, QC, Warehouse, and &nbsp;Production-(b)(4)Block.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u53e6\u5916\uff0c\u4f60\u516c\u53f8\u672a\u7ef4\u62a4\u548c\u4fdd\u5b58\u8fc7\u671f\u7684\u53f0\u8d26\u8bb0\u5f55\u3002\u4f8b\u5982\uff0c\u4e00\u65e6\u5b8c\u6210\uff0c\u4f60\u516c\u53f8\u5373\u628a\u4ee5\u4e0b\u533a\u57df\u7684\u53f0\u8d26\u8bb0\u5f55\u9500\u6bc1\uff1a<\/span>XX\u8f66\u95f4\u4ed3\u5e93\u3001\u5e93\u7ba1XX\u8f66\u95f4QC\u3001XX\u8f66\u95f4QA\u3001XX\u8f66\u95f4\u751f\u4ea7\u3001XX\u8f66\u95f4\u3001QC\u3001\u4ed3\u5e93\u548c\u751f\u4ea7-XX\u8f66\u95f4\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">As recent as 2018, the destruction of logbook examples include, but are not &nbsp;limited to: Notification Record for Invalid Data, Line Clearance Checklist, &nbsp;Preventive Maintenance, Instrument Logbooks, training records, cleaning check &nbsp;lists.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u8fd1\u81f3<\/span>2018\u5e74\uff0c\u53f0\u8d26\u8bb0\u5f55\u7684\u9500\u6bc1\u4f8b\u5b50\u5305\u62ec\u4f46\u4e0d\u4ec5\u9650\u4e8e\uff1a\u65e0\u6548\u6570\u636e\u901a\u77e5\u8bb0\u5f55\u3001\u6e05\u573a\u8bb0\u5f55\u3001\u9884\u9632\u6027\u7ef4\u62a4\u8bb0\u5f55\u3001\u4eea\u5668\u65e5\u5fd7\u3001\u57f9\u8bad\u8bb0\u5f55\u3001\u6e05\u6d01\u68c0\u67e5\u6e05\u5355\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 27px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5e8f\u53f7\uff1a<\/span>14<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u5173\u952e\u8bcd\uff1a\u6570\u636e\u53ef\u9760\u6027\uff0c\u7f51\u7edc\u5b58\u50a8\u6570\u636e\u7684\u5220\u9664<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u6765\u6e90\uff1a<\/span>FDA 483<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u53d1\u5e03\u65e5\u671f\uff1a<\/span>20180411<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f01\u4e1a\u540d\u79f0\uff1a\u5370\u5ea6<\/span>Alkem Laboratories<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u9879\u63cf\u8ff0\uff1a<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">A Your firm\u2019s QC department deleted two-thousand one hundred one (2,101) &nbsp;files since 1March 2018 on your network. These files names include, but are not &nbsp;limited to: OOS, OOT, Incidents, Method Verification Reports, chromatographs, &nbsp;calculations, and Stability Reports.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f60\u516c\u53f8\u7684<\/span>QC\u90e8\u95e8\u81ea2018-03-01\u8d77\u4ece\u4f60\u4eec\u7f51\u7edc\u4e0a\u5220\u9664\u4e862101\u4e2a\u6587\u4ef6\u3002\u8fd9\u4e9b\u6587\u4ef6\u540d\u79f0\u5305\u62ec\u4f46\u4e0d\u4ec5\u9650\u4e8eOOS\u3001OOT\u3001\u4e8b\u4ef6\u3001\u65b9\u6cd5\u786e\u8ba4\u62a5\u544a\u3001\u8272\u8c31\u3001\u8ba1\u7b97\u548c\u7a33\u5b9a\u6027\u62a5\u544a\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 27px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5e8f\u53f7\uff1a<\/span>15<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u5173\u952e\u8bcd\uff1a\u6570\u636e\u53ef\u9760\u6027\uff0c\u5b9e\u9a8c\u5ba4\u8bb0\u5f55<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u6765\u6e90\uff1a<\/span>FDA 483<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u53d1\u5e03\u65e5\u671f\uff1a<\/span>20180411<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f01\u4e1a\u540d\u79f0\uff1a\u5370\u5ea6<\/span>Alkem Laboratories<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u9879\u63cf\u8ff0\uff1a<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Laboratory records do not include complete data derived from all tests, &nbsp;examinations and assay necessary to assure compliance with established &nbsp;specifications and standards. Electronic records are used, but they do not meet &nbsp;requirements to ensure that they are trustworthy, reliable and generally &nbsp;equivalent to paper records.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5b9e\u9a8c\u5ba4\u8bb0\u5f55\u672a\u5305\u62ec\u4e3a\u786e\u4fdd\u7b26\u5408\u65e2\u5b9a\u89c4\u683c\u548c\u6807\u51c6\u800c\u8fdb\u884c\u7684\u6240\u6709\u6d4b\u8bd5\u3001\u68c0\u67e5\u548c\u542b\u91cf\u4e2d\u751f\u6210\u7684\u5b8c\u6574\u6570\u636e\u3002\u4f7f\u7528\u4e86\u7535\u5b50\u8bb0\u5f55\uff0c\u4f46\u5b83\u4eec\u65e0\u6cd5\u786e\u4fdd\u5176\u53ef\u4fe1\u5ea6\u3001\u53ef\u9760\u5ea6\u548c\u7b49\u540c\u4e8e\u7eb8\u8d28\u8bb0\u5f55\u7684\u6548\u529b\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 27px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5e8f\u53f7\uff1a<\/span>16<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u5173\u952e\u8bcd\uff1a\u6570\u636e\u53ef\u9760\u6027\uff0c<\/span>EXCEL\u8868\u683c\u4e0d\u53d7\u63a7<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u6765\u6e90\uff1a<\/span>FDA 483<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u53d1\u5e03\u65e5\u671f\uff1a<\/span>20180411<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f01\u4e1a\u540d\u79f0\uff1a\u5370\u5ea6<\/span>Alkem Laboratories<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u9879\u63cf\u8ff0\uff1a<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">A During the inspection, we observed two (2) different QC lab analyst &nbsp;demonstrate the ability to change calculation function in the excel spreadsheet &nbsp;used for finished product testing for the following:<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5728\u68c0\u67e5\u671f\u95f4\uff0c\u6211\u4eec\u53d1\u73b0<\/span>2\u4e2a\u4e0d\u540c\u7684QC\u5206\u6790\u5458\u53ef\u4ee5\u4fee\u6539\u6210\u54c1\u68c0\u6d4b\u6240\u7528EXCEL\u8868\u683c\u4e2d\u7684\u8ba1\u7b97\u529f\u80fd\u5982\u4e0b\uff1a<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">(1) On 22 March 2018, we observed your QC Analyst use an uncontrolled excel &nbsp;spreadsheet to calculate the Average, Standard Deviation, and %RSD values for &nbsp;(b)(4) Tablets, Batch #(b)(4) product release testing. The use of this &nbsp;spreadsheet is not mentioned in any written procedure when conducting (b)(4) &nbsp;Product Release Testing. In addition, this excel spreadsheet is not saved or &nbsp;printed. Therefore, the QC Reviewer is unable to verify these calculations are &nbsp;correct and the correct formula was used.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">2018-03-22\uff0c\u6211\u4eec\u53d1\u73b0\u4f60\u4eecQC\u5206\u6790\u5458\u4f7f\u7528\u4e86\u4e00\u4e2a\u672a\u53d7\u63a7\u7684EXCEL\u8868\u683c\u6765\u8ba1\u7b97XX\u7247\u5242XX\u6279\u53f7\u4ea7\u54c1\u653e\u884c\u6d4b\u8bd5\u4e2d\u7684\u5e73\u5747\u503c\u3001\u6807\u51c6\u504f\u5dee\u548c%RSD\u503c\u3002\u5728\u6240\u6709\u4e66\u9762\u7a0b\u5e8f\u4e2d\u5747\u672a\u63d0\u53ca\u5b9e\u65bdXX\u4ea7\u54c1\u653e\u884c\u6d4b\u8bd5\u4e2d\u4f7f\u7528\u6b64\u8868\u683c\u3002\u53e6\u5916\uff0c\u8be5EXCEL\u8868\u683c\u5e76\u672a\u4fdd\u5b58\u6216\u6253\u5370\u3002\u56e0\u6b64\uff0cQC\u590d\u6838\u4eba\u5458\u65e0\u6cd5\u786e\u8ba4\u8fd9\u4e9b\u8ba1\u7b97\u662f\u5426\u6b63\u786e\uff0c\u6240\u7528\u516c\u5f0f\u662f\u5426\u6b63\u786e\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">(2) On 23 March 2018, we observed the QC Reviewer use an uncontrolled excel &nbsp;spreadsheet to verify the potency of (b)(4) working standard during the &nbsp;Analytical Worksheet review for (b)(4) Tablets, Batch #(b)(4). The use of this &nbsp;spreadsheet is not mentioned in any written procedure when conducting Analytical &nbsp;Report reviews.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">2018-03-23\uff0c\u6211\u4eec\u53d1\u73b0\u8be5QC\u5ba1\u6838\u4eba\u5458\u5728\u5ba1\u6838XX\u7247\u5242XX\u6279\u53f7\u7684\u5206\u6790\u5de5\u4f5c\u8868\u8fc7\u7a0b\u4e2d\u4f7f\u7528\u4e86\u672a\u53d7\u63a7\u7684EXCEL\u8868\u683c\u6765\u6838\u5b9eXX\u5de5\u4f5c\u6807\u51c6\u7684\u6548\u4ef7\u3002\u5728\u6240\u6709\u4e66\u9762\u7a0b\u5e8f\u4e2d\u5747\u672a\u63d0\u53ca\u5728\u6267\u884c\u5206\u6790\u62a5\u544a\u5ba1\u6838\u65f6\u4f7f\u7528\u6b64\u8868\u683c\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">B. On 19 March 2018, we observed your QC Manager\u2019s use an excel spreadsheet &nbsp;to track quality functions, such as stability samples. This document is not &nbsp;maintained through document control and there is no protection from data &nbsp;manipulation, overwriting, erasing of data, or audit trails.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">2018-03-19\uff0c\u6211\u4eec\u53d1\u73b0\u4f60\u4eecQC\u7ecf\u7406\u4f7f\u7528\u4e86\u4e00\u4efdEXCEL\u8868\u683c\u8ffd\u8e2a\u8d28\u91cf\u51fd\u6570\uff0c\u4f8b\u5982\u7a33\u5b9a\u6027\u6837\u54c1\u3002\u6b64\u8868\u683c\u5e76\u672a\u6309\u7167\u6587\u4ef6\u53d7\u63a7\u7684\u539f\u5219\u8fdb\u884c\u7ef4\u62a4\uff0c\u4ea6\u65e0\u9632\u6b62\u6570\u636e\u7be1\u6539\u3001\u6539\u5199\u3001\u6570\u636e\u64e6\u9664\u6216\u5ba1\u8ba1\u8ffd\u8e2a\u7684\u624b\u6bb5\u6765\u8fdb\u884c\u4fdd\u62a4\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">C. On 19 March 2018, during the inspection, we observed two (2) (b)(4) &nbsp;employees use an uncontrolled spreadsheet to calculate due dates used during the &nbsp;manufacturing and packaging of drug products.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">2018-03-19\uff0c\u5728\u68c0\u67e5\u671f\u95f4\uff0c\u6211\u4eec\u53d1\u73b02\u4e2aXX\u5458\u5de5\u4f7f\u7528\u4e86\u672a\u53d7\u63a7\u8868\u683c\u6765\u8ba1\u7b97\u836f\u54c1\u751f\u4ea7\u548c\u5305\u88c5\u4e2d\u6240\u7528\u7684\u6709\u6548\u671f\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">(1) For example, but not limited to, the (b)(4) stage is to be completed &nbsp;within (b)(4) initiating the compressed tablet stage. However, the dates used to &nbsp;calculate these timeframes has not been validated. In addition, this spreadsheet &nbsp;was no password protected.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f8b\u5b50\u5305\u62ec\u4f46\u4e0d\u9650\u4e8e\uff0c<\/span>XX\u6b65\u9aa4\u662f\u5728\u538b\u7247\u5f00\u59cb\u4e4b\u540eXX\u65f6\u95f4\u5185\u5b8c\u6210\u3002\u4f46\u662f\u7528\u4e8e\u8ba1\u7b97\u8fd9\u4e9b\u65f6\u95f4\u7684\u65e5\u671f\u5e76\u672a\u7ecf\u8fc7\u9a8c\u8bc1\u3002\u6b64\u5916\u8fd9\u4e9b\u8868\u683c\u4ea6\u65e0\u5bc6\u7801\u4fdd\u62a4\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 27px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5e8f\u53f7\uff1a<\/span>17<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u5173\u952e\u8bcd\uff1a\u6570\u636e\u53ef\u9760\u6027\uff0c\u539f\u59cb\u6570\u636e<\/span>&nbsp;<span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5b9e\u9a8c\u5ba4\u8bb0\u5f55<\/span><\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u6765\u6e90\uff1a<\/span>FDA 483<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u53d1\u5e03\u65e5\u671f\uff1a<\/span>20180411<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f01\u4e1a\u540d\u79f0\uff1a\u5370\u5ea6<\/span>Alkem Laboratories<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u9879\u63cf\u8ff0\uff1a<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Established laboratory control mechanisms are not documented at the time of &nbsp;performance.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5728\u8fdb\u884c\u5b9e\u9a8c\u5ba4\u68c0\u6d4b\u65f6\u672a\u672a\u6309\u65e2\u5b9a\u7684\u5b9e\u9a8c\u5ba4\u63a7\u5236\u673a\u5236\u8fdb\u884c\u8bb0\u5f55\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Specifically, \u5177\u4f53\u6765\u8bf4<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">A. During our inspection of the QC laboratory on 19 March 2018, we observed &nbsp;your QC Analyst entering data electronically into an excel spreadsheet, in the &nbsp;absence of raw data. This same data was also entered into the 9M Stability Study &nbsp;Logbook for (b)(4) Tablets (b)(4)mg, Batch #(b)(4), manufactured April 2017 &nbsp;(2months late).<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5728<\/span>2018-03-19\u6211\u4eec\u5bf9QC\u5b9e\u9a8c\u5ba4\u68c0\u67e5\u671f\u95f4\uff0c\u53d1\u73b0\u4f60\u4eecQC\u5206\u6790\u5458\u5c06\u7535\u5b50\u6570\u636e\u5f55\u5165\u5230\u4e00\u4e2aEXCEL\u8868\u683c\u4e2d\uff0c\u800c\u6ca1\u6709\u539f\u59cb\u6570\u636e\u3002\u540c\u6837\u7684\u6570\u636e\u4ea6\u88ab\u5f55\u5165\u751f\u4ea7\u65e5\u671f\u4e3a2017\u5e744\u6708\u7684XX\u7247\u5242XX\u6279\u53f7\u76849\u4e2a\u6708\u7a33\u5b9a\u6027\u7814\u7a76\u767b\u8bb0\u672c(\u5ef6\u8fdf2\u4e2a\u6708)\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">B. On 23 March 2018, we observed a QC Executive reviewing an OOS\/OOT &nbsp;investigation for(b)(4) mg Tablets, Batch #(b)(4) where the stability and &nbsp;scoring study were OOT. The employee had a pen for signing for the review, but &nbsp;no checklist, paper, or workstation for recording errors. In the event of an &nbsp;error the employee reported, they would notify the Section Head and Analyst, but &nbsp;not document it.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">2018-03-23\uff0c\u6211\u4eec\u53d1\u73b0\u4e00\u4f4dQC\u7ecf\u7406\u6b63\u5ba1\u6838\u4e00\u4efdXX\u7247\u5242XX\u6279\u53f7\u7684OOS\/OOT\u8c03\u67e5\uff0c\u8be5\u7a33\u5b9a\u6027\u548c\u5206\u7ea7\u8c03\u67e5\u4e3aOOT\u3002\u8be5\u5458\u5de5\u6709\u4e00\u652f\u94a2\u7b14\u7528\u4e8e\u5ba1\u6838\u7b7e\u5b57\uff0c\u4f46\u5e76\u6ca1\u6709\u68c0\u67e5\u6e05\u5355\u3001\u7eb8\u6216\u5de5\u4f5c\u7ad9\u6765\u8bb0\u5f55\u9519\u8bef\u3002\u5728\u5458\u5de5\u62a5\u544a\u9519\u8bef\u65f6\uff0c\u4ed6\u4eec\u5c31\u53e3\u5934\u901a\u77e5\u5206\u533a\u9886\u5bfc\u548c\u5206\u6790\u5458\uff0c\u65e0\u7eb8\u8d28\u8bb0\u5f55\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">C. On 23 March 2018, we observed an Analytical Worksheet for Raw Materials &nbsp;for (b)(4), Batch #(b)(4), did not contain any data for the UV conducted on 13 &nbsp;March 2018. The QC Analyst that conducted this analysis stated he did not &nbsp;document these recordings on the Analytical Worksheet because his data packet &nbsp;was removed by other Analysts without his knowledge.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">2018-03-23\uff0c\u6211\u4eec\u53d1\u73b0\u4e00\u4e2aXX\u4ea7\u54c1XX\u6279\u53f7\u539f\u6599\u7684\u5206\u6790\u8bb0\u5f55\u4e2d\u5e76\u65e02018-03-13\u6240\u8fdb\u884c\u7684UV\u68c0\u6d4b\u6570\u636e\u3002\u6267\u884c\u6b64\u68c0\u6d4b\u7684QC\u5206\u6790\u5458\u58f0\u79f0\u4ed6\u5e76\u672a\u5c06\u8fd9\u4e9b\u8bb0\u5f55\u5728\u5206\u6790\u8bb0\u5f55\u4e0a\uff0c\u56e0\u4e3a\u4ed6\u7684\u6570\u636e\u5305\u5728\u4ed6\u4e0d\u77e5\u60c5\u7684\u60c5\u51b5\u4e0b\u88ab\u522b\u7684\u5206\u6790\u5458\u6e05\u9664\u4e86\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">D. On 22 March 2018, we observed a manufacturing employee entering tablets &nbsp;weights non-contemporaneously during the manufacturing of (b)(4) tablets USP &nbsp;(b)(4)mg, Batch # (b)(4) in the (b)(4) Block building.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">2018-03-22\uff0c\u6211\u4eec\u53d1\u73b0\u4e00\u4f4d\u751f\u4ea7\u5458\u5de5\u5728XX\u8f66\u95f4\u751f\u4ea7XX\u6279\u6b21\u7684XXmg USP\u89c4\u683c\u7684XX\u7247\u5242\u65f6\uff0c\u672a\u540c\u6b65\u5f55\u5165\u7247\u5242\u91cd\u91cf\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 27px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5e8f\u53f7\uff1a<\/span>18<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u5173\u952e\u8bcd\uff1a\u6570\u636e\u53ef\u9760\u6027\uff0c\u4eba\u5458\u6743\u9650<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u6765\u6e90\uff1a<\/span>FDA 483<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u53d1\u5e03\u65e5\u671f\uff1a<\/span>20180411<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f01\u4e1a\u540d\u79f0\uff1a\u5370\u5ea6<\/span>Alkem Laboratories<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u9879\u63cf\u8ff0\uff1a<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">All processing lines and major equipment used during the production of a &nbsp;batch of drug product is not properly identified at all times to indicate the &nbsp;phase of processing of the batch. Electronic signatures based on are used, but &nbsp;they do not meet the requirements of 21 CFR Part 11.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u6240\u6709\u7528\u4e8e\u4e00\u4e2a\u6279\u6b21\u836f\u54c1\u751f\u4ea7\u7684\u751f\u4ea7\u7ebf\u548c\u4e3b\u8981\u8bbe\u5907\u672a\u8fdb\u884c\u6070\u5f53\u8bc6\u522b\u4ee5\u663e\u793a\u5176\u6240\u9002\u7528\u7684\u6279\u5904\u7406\u9636\u6bb5\u3002\u4f7f\u7528\u4e86\u7535\u5b50\u7b7e\u540d\uff0c\u4f46\u4e0d\u7b26\u5408<\/span>21CFR\u7b2c11\u90e8\u5206\u8981\u6c42\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">Specifically, \u5177\u4f53\u6765\u8bf4<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">A. Your firm uses Programmable Logic Controllers (PLC) equipment during the &nbsp;manufacturing of drug products, which require a password and user name to &nbsp;operate. Your firm uses the following manufacturing PLC equipment that are not &nbsp;password protected:<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f60\u516c\u53f8\u5728\u836f\u54c1\u751f\u4ea7\u4e2d\u4f7f\u7528\u4e86<\/span>PLC\u8bbe\u5907\uff0c\u9700\u8981\u4e00\u4e2a\u5bc6\u7801\u548c\u7528\u6237\u540d\u6765\u64cd\u4f5c\u3002\u4f60\u516c\u53f8\u4f7f\u7528\u4e86\u4ee5\u4e0b\u751f\u4ea7PLC\u8bbe\u5907\uff0c\u4f46\u65e0\u5bc6\u7801\u4fdd\u62a4\uff1a<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 27px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5e8f\u53f7\uff1a<\/span>19<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u5173\u952e\u8bcd\uff1a\u6570\u636e\u5b8c\u6574\u6027\uff0c\u7f3a\u5c11\u4e8b\u4ef6\u62a5\u544a<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u6765\u6e90\uff1a<\/span>FDA 483<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u53d1\u5e03\u65e5\u671f\uff1a<\/span>20180321<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4f01\u4e1a\u540d\u79f0\uff1a<\/span>Dr. Reddy\u2019s<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f3a\u9677\u9879\u63cf\u8ff0\uff1a<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">The Empower 3 audit trail used in the QC laboratory for data acquisition &nbsp;system revealed on 2018-02-14 that Sample Set ID 2793, Sample Method #14318050 &nbsp;was aborted after injection #6 during system suitability for Agilent HPLC &nbsp;#QC-143, Per SOP #GQA032-01 (Handling of Incidents) 2017-09-15 effective date, &nbsp;an incident report is to be raised. However, at the time of the inspection no &nbsp;incident report was generated or explanation was documented on why this sample &nbsp;set was aborted.<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">QC\u7528\u4f5c\u6570\u636e\u91c7\u96c6\u7cfb\u7edf\u7684Empower 3\u7684\u5ba1\u8ba1\u8ffd\u8e2a\u663e\u793a\u57282018-02-14\u6709\u4e00\u4e2a\u8fdb\u6837\u5e8f\u5217\u53f7\u4e3a2793\uff0c\u6837\u54c1\u65b9\u6cd5#14318050\u5728Agilent &nbsp;HPLC #QC-143\u7cfb\u7edf\u9002\u7528\u6027\u8fd0\u884c\u4e2d#6\u9488\u8fdb\u6837\u540e\u88ab\u4e2d\u65ad\uff0c\u4f9dSOP &nbsp;#GQA032-01(\u4e8b\u6545\u5904\u7406)\uff0c\u751f\u6548\u65e5\u671f2017-09-15\uff0c\u5e94\u63d0\u4ea4\u4e00\u4efd\u4e8b\u4ef6\u62a5\u544a\u3002\u4f46\u662f\uff0c\u76f4\u5230\u68c0\u67e5\u65f6\u90fd\u6ca1\u6709\u586b\u5199\u4e8b\u4ef6\u62a5\u544a\uff0c\u4e5f\u6ca1\u6709\u6587\u4ef6\u8bb0\u5f55\u4e3a\u4ec0\u4e48\u8981\u4e2d\u6b62\u8fd9\u4e2a\u8fdb\u6837\u5e8f\u5217\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;background: rgb(255, 255, 255);\"><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6765\u6e90\uff1a<\/span><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6d1b<\/span><span style=\"max-width: 100%;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 1px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u65bd\u5fb7GMP\u54a8\u8be2<\/span><\/p>\n<p style=\"font-size: 16px;line-height: 25.6px;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);box-sizing: border-box !important;word-wrap: break-word !important;background-color: rgb(255, 255, 255);\"><span style=\"max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;text-align: center;line-height: 25.6px;font-family: \u5fae\u8f6f\u96c5\u9ed1;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;font-size: 16px;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;line-height: 25.6px;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;font-size: 16px;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;line-height: 25.6px;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;font-size: 16px;letter-spacing: 0.5px;line-height: 25.6px;text-align: justify;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 12px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(166, 166, 166);line-height: 22.72px;font-family: \u5b8b\u4f53;white-space: pre-wrap;box-sizing: border-box !important;word-wrap: break-word !important;\"><\/span><\/span><\/strong><\/span><\/strong><\/span><\/strong><\/span><\/strong><\/span><\/p>\n<p style=\"font-size: 16px;line-height: 25.6px;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);box-sizing: border-box !important;word-wrap: break-word !important;background-color: rgb(255, 255, 255);\"><span style=\"max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;text-align: center;line-height: 25.6px;font-family: \u5fae\u8f6f\u96c5\u9ed1;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;font-size: 16px;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;line-height: 25.6px;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;font-size: 16px;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;line-height: 25.6px;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;font-size: 16px;letter-spacing: 0.5px;line-height: 25.6px;text-align: justify;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 12px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(166, 166, 166);line-height: 22.72px;font-family: \u5b8b\u4f53;white-space: pre-wrap;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"color: rgb(62, 62, 62);font-size: 16px;line-height: 25.6px;white-space: normal;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;text-align: center;line-height: 25.6px;font-family: \u5fae\u8f6f\u96c5\u9ed1;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;font-size: 16px;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;line-height: 25.6px;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;font-size: 16px;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;line-height: 25.6px;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;font-size: 16px;line-height: 25.6px;text-align: justify;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 12px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(166, 166, 166);line-height: 22.72px;font-family: \u5b8b\u4f53;white-space: pre-wrap;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"color: rgb(2, 30, 170);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 27.2px;text-decoration: underline;\"><\/span><\/span><\/span><\/strong><\/span><\/strong><\/span><\/strong><\/span><\/strong><\/span><\/span><\/strong><\/span><\/strong><\/span><\/strong><\/span><\/strong><\/span><\/p>\n<section style=\"padding-right: 1em;padding-left: 1em;font-size: 16px;white-space: normal;max-width: 100%;box-sizing: border-box;color: rgb(51, 51, 51);font-family: monospace;letter-spacing: 0.544px;text-align: center;line-height: 28.44px;display: inline-block;word-wrap: break-word !important;background-color: rgb(255, 255, 255);\"><strong style=\"max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;letter-spacing: 0.5px;line-height: 25.6px;text-align: justify;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"color: rgb(62, 62, 62);line-height: 25.6px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"padding: 0.3em 0.5em;max-width: 100%;box-sizing: border-box;color: rgb(255, 255, 255);font-size: 14.08px;display: inline-block;box-shadow: rgb(165, 165, 165) 4px 4px 2px;word-wrap: break-word !important;background-color: rgb(95, 156, 239);\"><\/p>\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7248\u6743\u58f0\u660e<\/strong><\/section>\n<p><\/span><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/section>\n<p style=\"line-height: 25.6px;white-space: normal;\"><br  \/><\/p>\n<section style=\"margin-top: -1em;padding: 20px 10px 10px;font-size: 16px;line-height: 25.6px;white-space: normal;max-width: 100%;box-sizing: border-box;color: rgb(51, 51, 51);font-family: monospace;letter-spacing: 0.544px;text-align: center;border: 1px solid rgb(204, 204, 204);box-shadow: rgb(165, 165, 165) 4px 4px 2px;word-wrap: break-word !important;background-color: rgb(254, 255, 255);\">\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;text-align: left;word-wrap: break-word !important;\">\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 12px;line-height: normal;box-sizing: border-box !important;word-wrap: break-word !important;background-color: rgb(255, 255, 255);\"><\/span><strong style=\"line-height: 25.6px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;background-color: rgb(255, 255, 255);\"><span style=\"max-width: 100%;text-align: center;line-height: 25.6px;font-family: \u5fae\u8f6f\u96c5\u9ed1;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;font-size: 16px;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;line-height: 25.6px;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;font-size: 16px;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;line-height: 25.6px;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;font-size: 16px;letter-spacing: 0.5px;line-height: 25.6px;text-align: justify;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"line-height: 25.6px;max-width: 100%;font-size: 12px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;line-height: 22.72px;font-family: \u5b8b\u4f53;white-space: pre-wrap;\">\u514d\u8d23\u58f0\u660e\uff1a\u6587\u7ae0<\/span><span style=\"max-width: 100%;line-height: 22.72px;font-family: \u5b8b\u4f53;white-space: pre-wrap;\">\u7248\u6743\u5f52\u539f\u4f5c\u8005\u6240\u6709\u3002\u5982\u6d89\u53ca\u4f5c\u54c1\u5185\u5bb9\u3001\u7248\u6743\u548c\u5176\u5b83\u95ee\u9898\uff0c\u8bf7\u8ddf\u6211\u4eec\u8054\u7cfb\u5220\u9664\uff01\u6587\u7ae0\u5185\u5bb9\u4e3a\u4f5c\u8005\u4e2a\u4eba\u89c2\u70b9,\u5e76\u4e0d\u4ee3\u8868\u672c\u516c\u4f17\u53f7\u8d5e\u540c\u6216\u652f\u6301\u5176\u89c2\u70b9\u3002\u672c\u516c\u4f17\u53f7\u62e5\u6709\u5bf9\u6b64\u58f0\u660e\u7684\u6700\u7ec8\u89e3\u91ca\u6743\u3002<\/span><\/span><\/strong><\/span><\/strong><\/span><\/strong><\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<p style=\"font-size: 16px;line-height: 25.6px;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);box-sizing: border-box !important;word-wrap: break-word !important;background-color: rgb(255, 255, 255);\"><span style=\"max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;text-align: center;line-height: 25.6px;font-family: \u5fae\u8f6f\u96c5\u9ed1;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp; &nbsp; &nbsp;&nbsp;<\/span><\/strong><\/span><span style=\"max-width: 100%;line-height: 25.6px;color: rgb(255, 0, 0);box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;text-align: center;line-height: 25.6px;font-family: \u5fae\u8f6f\u96c5\u9ed1;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;\u626b\u63cf\u5173\u6ce8\u4e8c\u7ef4\u7801\uff0c<strong style=\"max-width: 100%;font-size: 16px;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;line-height: 25.6px;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6bcf\u5929\u90fd\u6709\u836f\u5c4a\u65b0\u95fb\u548c<\/span><\/strong><\/span><\/strong><strong style=\"max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;text-align: center;line-height: 25.6px;font-family: \u5fae\u8f6f\u96c5\u9ed1;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;font-size: 16px;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;line-height: 25.6px;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8bfe\u4ef6\u4e0e\u5927\u5bb6\u4e00\u8d77\u5206\u4eab\u3002<\/span><\/strong><\/span><\/strong><\/span><\/p>\n<p style=\"font-size: 16px;line-height: 25.6px;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);box-sizing: border-box !important;word-wrap: break-word !important;background-color: rgb(255, 255, 255);\"><img class=\"__bg_gif\"      width=\"auto\" style=\"box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;width: auto !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/09\/6-1538272378.gif\" alt=\"\u3010FDA\u3011FDA2018\u5e74483\u62a5\u544a\u4e0e\u8b66\u544a\u4fe1\u6c47\u603b\u7bc7\uff1a\u6570\u636e\u53ef\u9760\u6027\u7f3a\u9677\" title=\"\u3010FDA\u3011FDA2018\u5e74483\u62a5\u544a\u4e0e\u8b66\u544a\u4fe1\u6c47\u603b\u7bc7\uff1a\u6570\u636e\u53ef\u9760\u6027\u7f3a\u9677\"  \/><\/p>\n<section class=\"\"  style=\"font-size: 16px;line-height: 25.6px;white-space: normal;max-width: 100%;box-sizing: border-box;color: rgb(62, 62, 62);word-wrap: break-word !important;\">\n<section class=\"\" style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"padding: 10px;max-width: 100%;box-sizing: border-box;border: 0.8em solid;-webkit-border-image: url(&quot;https:\/\/mmbiz.qpic.cn\/mmbiz_png\/eDotHGpLa9iaVykicX5tjlhGZ5jW3oibriaF82BicV2NNj6Plb10qgnQxMbla2HOAjibV5lOeNW4RqjYShjEuZnAg3bQ\/640?wx_fmt=png&quot;) 54 fill;word-wrap: break-word !important;\">\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;text-align: center;word-wrap: break-word !important;\">\n<p style=\"line-height: 25.6px;\"><span style=\"color: rgb(172, 57, 255);\"><strong><span style=\"background-color: rgb(255, 251, 0);\">\u8fd1\u671f\u57f9\u8bad<span style=\"line-height: 1.6;\">\u70b9\u51fb\u53f3\u4fa7\u57f9\u8bad\u94fe\u63a5\u5373\u53ef\u9605\u8bfb\u539f\u6587<\/span><\/span><\/strong><\/span><br  \/><\/p>\n<table cellpadding=\"0\" cellspacing=\"0\">\n<colgroup>\n<col width=\"98\" style=\"width: 99px;\"  \/>\n<col width=\"110\" style=\"width: 111px;\"  \/>\n<col width=\"312\" style=\"width: 312px;\"  \/><\/colgroup>\n<tbody>\n<tr height=\"53\" style=\"height: 53px;\">\n<td height=\"53\" width=\"48\" style=\"word-break: break-all;\">\u5730\u70b9<\/td>\n<td width=\"192\" u1:str=\"\" style=\"border-left-style: none;max-width: 100%;word-break: break-all;word-wrap: break-word !important;box-sizing: border-box !important;\">&nbsp;\u65f6\u95f4<\/td>\n<td width=\"265\" u1:str=\"\" style=\"border-left-style: none;max-width: 100%;word-break: break-all;word-wrap: break-word !important;box-sizing: border-box !important;\">&nbsp; &nbsp;&nbsp; &nbsp;<span style=\"line-height: 25.6px;\">\u70b9\u5f00\u94fe\u63a5\u9884\u89c8\u5168\u6587<\/span><\/td>\n<\/tr>\n<tr>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"48\" style=\"word-break: break-all;\">\u676d\u5dde<\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"157\" style=\"word-break: break-all;\"><span style=\"color: rgb(51, 51, 51);line-height: 25.6px;orphans: 2;background-color: rgb(255, 255, 255);\">10\u670825-27\u65e5<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"265\" style=\"word-break: break-all;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247489898&amp;idx=6&amp;sn=491ac103b2baaa22cbd0b1239cba335b&amp;scene=21#wechat_redirect\" style=\"line-height: 25.6px;\"><strong style=\"color: rgb(62, 62, 62);line-height: 25.6px;\"><span style=\"font-family: Helvetica, sans-serif;\"><\/span><\/strong><\/a><strong style=\"line-height: 25.6px;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247490495&amp;idx=2&amp;sn=4d21c33850f33c85230e2fd2f4477d8c&amp;scene=21#wechat_redirect\"><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u7b2c\u4e8c\u671f\u201c<\/span><span style=\"font-weight: normal;\">2018<\/span><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u836f\u4f01<\/span><span style=\"font-weight: normal;\">OOS\/OOT<\/span><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u8c03\u67e5\u8bef\u533a\u4e0e\u6539\u8fdb\u5b9e\u64cd\u4e13\u9898\u57f9\u8bad\u73ed\u201d\u7684\u901a\u77e5<\/span><\/a><\/strong><\/td>\n<\/tr>\n<tr>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"48\" style=\"word-break: break-all;\"><span style=\"color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 25.6px;background-color: rgb(255, 255, 255);\">\u676d\u5dde<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"157\" style=\"word-break: break-all;\">10\u670811-13\u65e5<\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"265\" style=\"word-break: break-all;\"><strong style=\"line-height: 25.6px;\"><span style=\"font-family: Helvetica, sans-serif;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247490325&amp;idx=7&amp;sn=414375b65452c9af835b0ee04c0ec449&amp;scene=21#wechat_redirect\"><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u201c<\/span><span style=\"font-weight: normal;\">2018 cGMP<\/span><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u6587\u4ef6\u7f16\u5236\u89c4\u8303\u201d\u4e13\u9898\u7814\u4fee\u73ed<\/span><span style=\"font-weight: normal;\"><\/span><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u7684\u901a\u77e5<\/span><\/a><\/span><\/strong><\/td>\n<\/tr>\n<tr>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"48\" style=\"word-break: break-all;\"><span style=\"color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 25.6px;background-color: rgb(255, 255, 255);\">\u4e0a\u6d77<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"157\" style=\"word-break: break-all;\">10\u670812-14\u65e5<\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"265\" style=\"word-break: break-all;\">\n<p><strong><span style=\"font-family: Helvetica, sans-serif;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247490293&amp;idx=7&amp;sn=e1da9290f5188bd81daf001ba9b4b543&amp;scene=21#wechat_redirect\"><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u7b2c\u4e8c\u671f\u201c\u4e34\u5e8a\u8bd5\u9a8c\u7528\u836f<\/span><span style=\"font-weight: normal;\">GMP<\/span><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u5236\u5ea6\u8981\u70b9\u89e3\u6790\u53ca\u5e94\u7528\u5b9e\u65bd\u4e13\u9898\u57f9\u8bad\u73ed\u201d\u7684\u901a\u77e5<\/span><\/a><\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"48\" style=\"word-break: break-all;\"><span style=\"color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 25.6px;background-color: rgb(255, 255, 255);\">\u6b66\u6c49<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"157\" style=\"word-break: break-all;\">10\u670819-21\u65e5<\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"265\" style=\"word-break: break-all;\">\n<p><strong><span style=\"font-family: Helvetica, sans-serif;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247490293&amp;idx=6&amp;sn=4371c44dff5e93974c21d2bae981320c&amp;scene=21#wechat_redirect\"><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u201c<\/span><span style=\"font-weight: normal;\">2018<\/span><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u836f\u4f01\u7ea0\u6b63\u4e0e\u9884\u9632\u63aa\u65bd\u5b9e\u65bd\u4e0e\u6539\u8fdb\u4e13\u9898\u57f9\u8bad\u73ed\u201d\u7684\u901a\u77e5<\/span><\/a><\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"48\" style=\"word-break: break-all;\"><span style=\"color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 25.6px;background-color: rgb(255, 255, 255);\">\u4e0a\u6d77<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"157\" style=\"word-break: break-all;\">10\u670819-21\u65e5<\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"265\" style=\"word-break: break-all;\"><strong style=\"line-height: 25.6px;\"><span style=\"font-family: Helvetica, sans-serif;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247490377&amp;idx=5&amp;sn=8e2a65a620ff54cdf971fc45f4552871&amp;scene=21#wechat_redirect\"><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u201c\u5316\u5b66\u539f\u6599\u836f\u5236\u5907\u5de5\u827a\u5f00\u53d1\u5173\u952e\u70b9\u63a7\u5236\u4e0e\u8d28\u91cf\u7814\u7a76\u5b9e\u8df5\u201d<\/span><span style=\"font-weight: normal;\"><\/span><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u7814\u4fee\u73ed\u7684\u901a\u77e5<\/span><\/a><\/span><\/strong><\/td>\n<\/tr>\n<tr>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"48\" style=\"word-break: break-all;\"><span style=\"color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 25.6px;background-color: rgb(255, 255, 255);\">\u5317\u4eac<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"157\" style=\"word-break: break-all;\">10\u670824-26\u65e5<\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"265\" style=\"word-break: break-all;\"><strong style=\"line-height: 25.6px;\"><span style=\"font-family: Helvetica, sans-serif;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247490404&amp;idx=6&amp;sn=6c43b8c55387b96bc12d9ad37b19c0c2&amp;scene=21#wechat_redirect\"><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u201c\u6ee1\u8db3\u6b27\u7f8e\u6807\u51c6\u7684\u4eff\u5236\u836f\u7814\u53d1\u4f53\u7cfb\u642d\u5efa\u201d<\/span><span style=\"font-weight: normal;\"><\/span><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u7814\u4fee\u73ed\u7684\u901a\u77e5<\/span><\/a><\/span><\/strong><\/td>\n<\/tr>\n<tr>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"48\" style=\"word-break: break-all;\"><span style=\"color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 25.6px;background-color: rgb(255, 255, 255);\">\u5357\u4eac<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"157\" style=\"word-break: break-all;\">10\u670825-27\u65e5<\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"265\" style=\"word-break: break-all;\">\n<p><strong><span style=\"font-family: Helvetica, sans-serif;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247490293&amp;idx=5&amp;sn=ca0f0efb8853d9cf71fa52cf94c1bd38&amp;scene=21#wechat_redirect\"><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u201c\u836f\u7269\u7814\u53d1\u8d28\u91cf\u7ba1\u7406\u8fd0\u884c\u96be\u70b9\u5b9e\u65bd\u53ca\u4e34\u5e8a\u8bd5\u9a8c\u7528\u836f\u7269<\/span><span style=\"font-weight: normal;\">GMP<\/span><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u5b9e\u65bd\u5173\u952e\u70b9\u63a7\u5236\u201d\u9ad8\u7ea7\u7814\u4fee\u73ed\u7684\u901a\u77e5<\/span><\/a><\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;\"><span style=\"color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 25.6px;background-color: rgb(255, 255, 255);\">\u676d\u5dde<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;\">10\u670825\u65e5-27<\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;\">\n<p><strong><span style=\"font-family: Helvetica, sans-serif;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247490514&amp;idx=5&amp;sn=c10957861e536c5718d3899ada328bbf&amp;scene=21#wechat_redirect\"><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u201c<\/span><span style=\"font-weight: normal;\">2018<\/span><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u529f\u80fd\u98df\u54c1\u539f\u3001\u914d\u6599\u521b\u65b0\u4e0e\u6d3b\u6027\u6210\u5206\u5e94\u7528\u6280\u672f\u4e3b\u9898\u5cf0\u4f1a<\/span><span style=\"font-weight: normal;\"><\/span><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u66a8\u65b0\u6280\u672f\u3001\u65b0\u4ea7\u54c1\u3001\u65b0\u88c5\u5907\u5c55\u793a\u4f1a\u201d\u7684\u901a\u77e5<\/span><\/a><\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"48\" style=\"word-break: break-all;\"><span style=\"color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 25.6px;background-color: rgb(255, 255, 255);\">\u4e0a\u6d77<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"157\" style=\"word-break: break-all;\">10\u670826-28\u65e5<\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"265\" style=\"word-break: break-all;\"><strong style=\"line-height: 25.6px;\"><span style=\"font-family: Helvetica, sans-serif;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247490421&amp;idx=6&amp;sn=30d3b1f9d8655d1ca3fe25d3d9bc36ad&amp;scene=21#wechat_redirect\"><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u201c<\/span><span style=\"font-weight: normal;\">2018<\/span><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u836f\u4f01\u8d28\u91cf\u8c03\u67e5\u6280\u672f\u6307\u5bfc\u4e13\u9898\u57f9\u8bad\u73ed\u201d\u7684\u901a\u77e5<\/span><\/a><\/span><\/strong><\/td>\n<\/tr>\n<tr>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;\">\u6d4e\u5357<\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;\"><span style=\"color: rgb(51, 51, 51);line-height: 25.6px;orphans: 2;background-color: rgb(255, 255, 255);\">10\u670826-28\u65e5<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;\">\n<p><strong><span style=\"font-family: Helvetica, sans-serif;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247490574&amp;idx=5&amp;sn=a44be9027085e45f514dbfdef115697a&amp;scene=21#wechat_redirect\"><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u7b2c\u4e8c\u671f\u836f\u4f01\u5b9e\u9a8c\u5ba4\uff08\u7814\u53d1<\/span><span style=\"font-weight: normal;\">\/QC<\/span><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\uff09\u89c4\u8303\u7ba1\u7406\u4e0e<\/span><span style=\"font-weight: normal;\">&nbsp;ICH<\/span><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u6307\u5357\u53ca\u836f\u5178\u6700\u65b0\u8fdb\u5c55\u201d\u7814\u4fee\u73ed\u201d<\/span><\/a><\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;\"><span style=\"color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;background-color: rgb(255, 255, 255);\">\u5357\u4eac<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;\"><span style=\"color: rgb(51, 51, 51);line-height: 25.6px;orphans: 2;background-color: rgb(255, 255, 255);\">10\u670826-28\u65e5<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;\">\n<p><strong><span style=\"font-family: Helvetica, sans-serif;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247490636&amp;idx=6&amp;sn=9f3785a01a2c16f46ec4a4547a8fc276&amp;scene=21#wechat_redirect\"><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u201c<\/span><span style=\"font-weight: normal;\">2018<\/span><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u7cbe\u998f\u6280\u672f\u5e94\u7528\u53ca\u5de5\u7a0b\u8ba1\u7b97\u3001\u8bbe\u8ba1\u6848\u4f8b<\/span><span style=\"font-weight: normal;\"><\/span><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u7814\u8ba8\u4f1a\u201d\u7684\u901a\u77e5<\/span><\/a><\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;\"><span style=\"color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 27.2px;background-color: rgb(255, 255, 255);\">\u5357\u4eac<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;\"><span style=\"color: rgb(51, 51, 51);line-height: 25.6px;orphans: 2;background-color: rgb(255, 255, 255);\">10\u670827-29\u65e5<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;\"><strong style=\"line-height: 25.6px;\"><span style=\"font-family: Helvetica, sans-serif;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247490444&amp;idx=5&amp;sn=34d5640c491babbaeca5cec3f19986e0&amp;scene=21#wechat_redirect\"><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u201c\u5236\u836f\u4f01\u4e1a\u5982\u4f55\u5b9e\u73b0<\/span><span style=\"font-weight: normal;\">GMP<\/span><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u6709\u6548\u8fd0\u8425\u6c9f\u901a\u9ad8\u7ea7\u7814\u4fee\u73ed\u201d\u7684\u901a\u77e5<\/span><\/a><\/span><\/strong><\/td>\n<\/tr>\n<tr>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"48\" style=\"word-break: break-all;\"><span style=\"color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 25.6px;background-color: rgb(255, 255, 255);\">\u91cd\u5e86<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"157\" style=\"word-break: break-all;\">11\u67081-3\u65e5<\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"265\" style=\"word-break: break-all;\"><strong><span style=\"font-size: 14px;font-family: Helvetica, sans-serif;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247490354&amp;idx=5&amp;sn=927aba4b48057d041b1b074444a79995&amp;scene=21#wechat_redirect\"><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u201c\u836f\u54c1\u5236\u5907\u5de5\u827a\u5f00\u53d1\u4e0e\u5de5\u827a\u9a8c\u8bc1<\/span><span style=\"font-weight: normal;\">\/<\/span><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u7814\u7a76\u4e0e\u5b9e\u65bd\u201d\u7b2c\u4e94\u671f\u7814\u4fee\u73ed\u7684\u901a\u77e5<\/span><\/a><\/span><\/strong><\/td>\n<\/tr>\n<tr>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"48\" style=\"word-break: break-all;\">\u676d\u5dde<\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"157\" style=\"word-break: break-all;\">11\u67081-3\u65e5<\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"265\" style=\"word-break: break-all;\">\n<p><strong><span style=\"font-family: Helvetica, sans-serif;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247490377&amp;idx=6&amp;sn=6c8de57ddf9b4036f5976bb9249d1b5a&amp;scene=21#wechat_redirect\"><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u201c<\/span><span style=\"font-weight: normal;\">2018<\/span><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u533b\u836f\u5316\u5de5\u5b89\u5168\u751f\u4ea7\u4e0e\u5de5\u827a\u5b89\u5168\u7ba1\u7406\u7814\u8ba8\u73ed\u201d\u7684\u901a\u77e5<\/span><\/a><\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;\"><span style=\"line-height: 25.6px;\">\u5317\u4eac<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;\"><span style=\"color: rgb(51, 51, 51);line-height: 25.6px;orphans: 2;background-color: rgb(255, 255, 255);\">11\u67082-4\u65e5<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;\"><strong style=\"line-height: 25.6px;\"><span style=\"font-family: Helvetica, sans-serif;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247490636&amp;idx=5&amp;sn=e9c71f431841e9d953bd58cbdb1eb239&amp;scene=21#wechat_redirect\"><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u7b2c\u4e8c\u671f\u201c<\/span><span style=\"font-weight: normal;\">2018<\/span><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u56fd\u9645\u5316\u6ce8\u518c\u4e13\u5458\u6280\u80fd\u63d0\u5347\u4e13\u9898\u57f9\u8bad\u73ed\u201d<\/span><\/a><\/span><\/strong><\/td>\n<\/tr>\n<tr>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"48\" style=\"word-break: break-all;\"><span style=\"color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &#39;Helvetica Neue&#39;, &#39;PingFang SC&#39;, &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei UI&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;background-color: rgb(255, 255, 255);\">\u5e7f\u5dde<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"157\" style=\"word-break: break-all;\">11\u67089-11\u65e5<\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" width=\"265\" style=\"word-break: break-all;\">\n<p><strong><span style=\"font-family: Helvetica, sans-serif;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247490404&amp;idx=7&amp;sn=1823d319173bda6fe78cda04ffb9fbae&amp;scene=21#wechat_redirect\"><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u201c<\/span><span style=\"font-weight: normal;\">2018<\/span><span style=\"font-family: \u7b49\u7ebf;font-weight: normal;\">\u4e2d\u56fd\u7279\u6b8a\u533b\u5b66\u7528\u9014\u914d\u65b9\u98df\u54c1\u6ce8\u518c\u7533\u62a5\u3001\u914d\u65b9\u8bbe\u8ba1\u53ca\u751f\u4ea7\u5de5\u827a\u3001\u73b0\u573a\u6838\u67e5\u4e0e\u8d28\u91cf\u68c0\u9a8c\u4ea4\u6d41\u4f1a\u7684\u901a\u77e5<\/span><\/a><\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"\" style=\"margin-top: -15px;margin-left: auto;font-size: 16px;line-height: 25.6px;white-space: normal;max-width: 100%;box-sizing: border-box;color: rgb(62, 62, 62);width: 15px;height: 15px;word-wrap: break-word !important;background-color: rgb(255, 255, 255);\">\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"><\/section>\n<\/section>\n<section class=\"\"  style=\"font-size: 16px;line-height: 25.6px;white-space: normal;max-width: 100%;box-sizing: border-box;color: rgb(62, 62, 62);word-wrap: break-word !important;\">\n<section class=\"\" style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"padding: 10px;max-width: 100%;box-sizing: border-box;border: 0.8em solid;-webkit-border-image: url(&quot;https:\/\/mmbiz.qpic.cn\/mmbiz_png\/eDotHGpLa9iaVykicX5tjlhGZ5jW3oibriaF82BicV2NNj6Plb10qgnQxMbla2HOAjibV5lOeNW4RqjYShjEuZnAg3bQ\/640?wx_fmt=png&quot;) 54 fill;word-wrap: break-word !important;\">\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;box-sizing: border-box;text-align: center;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;vertical-align: middle;display: inline-block;word-wrap: break-word !important;overflow: hidden !important;\"><img class=\"\"     style=\"box-sizing: border-box;vertical-align: middle;word-wrap: break-word !important;width: auto !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/09\/3-1538272378.jpeg\" alt=\"\u3010FDA\u3011FDA2018\u5e74483\u62a5\u544a\u4e0e\u8b66\u544a\u4fe1\u6c47\u603b\u7bc7\uff1a\u6570\u636e\u53ef\u9760\u6027\u7f3a\u9677\" title=\"\u3010FDA\u3011FDA2018\u5e74483\u62a5\u544a\u4e0e\u8b66\u544a\u4fe1\u6c47\u603b\u7bc7\uff1a\u6570\u636e\u53ef\u9760\u6027\u7f3a\u9677\"  \/><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"\"  style=\"font-size: 16px;line-height: 25.6px;white-space: normal;max-width: 100%;box-sizing: border-box;color: rgb(62, 62, 62);word-wrap: break-word !important;\">\n<section class=\"\" style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;width: 15px;height: 15px;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;width: 5px;height: 5px;float: left;word-wrap: break-word !important;background-color: rgb(240, 82, 138);\"><\/section>\n<section style=\"max-width: 100%;box-sizing: border-box;width: 5px;height: 5px;float: left;word-wrap: break-word !important;background-color: rgb(254, 255, 255);\"><\/section>\n<section style=\"max-width: 100%;box-sizing: border-box;clear: both;word-wrap: break-word !important;\"><\/section>\n<\/section>\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;width: 5px;height: 5px;float: left;word-wrap: break-word !important;background-color: rgb(240, 82, 138);\"><\/section>\n<section style=\"max-width: 100%;box-sizing: border-box;width: 5px;height: 5px;float: left;word-wrap: break-word !important;background-color: rgb(254, 255, 255);\"><\/section>\n<section style=\"max-width: 100%;box-sizing: border-box;width: 5px;height: 5px;float: left;word-wrap: break-word !important;background-color: rgb(240, 82, 138);\"><\/section>\n<section style=\"max-width: 100%;box-sizing: border-box;clear: both;word-wrap: break-word !important;\"><\/section>\n<\/section>\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;width: 5px;height: 5px;float: left;word-wrap: break-word !important;background-color: rgb(254, 255, 255);\"><\/section>\n<section style=\"max-width: 100%;box-sizing: border-box;width: 5px;height: 5px;float: left;word-wrap: break-word !important;background-color: rgb(240, 82, 138);\"><\/section>\n<section style=\"max-width: 100%;box-sizing: border-box;width: 5px;height: 5px;float: left;word-wrap: break-word !important;background-color: rgb(240, 82, 138);\"><\/section>\n<section style=\"max-width: 100%;box-sizing: border-box;clear: both;word-wrap: break-word !important;\"><\/section>\n<\/section>\n<\/section>\n<section class=\"\" style=\"margin-top: -15px;padding: 10px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;background-color: rgb(240, 82, 138);\">\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;color: rgb(71, 193, 168);text-align: center;word-wrap: break-word !important;\">\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;\"><span style=\"font-size: 20px;background-color: rgb(255, 251, 0);\"><strong style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\u62a5\u540d\u8bf7\u626b\u63cf\u4e8c\u7ef4\u7801\u52a0\u8d1f\u8d23\u4eba\u5fae\u4fe1<\/strong><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<p style=\"line-height: 25.6px;white-space: normal;\"><span style=\"line-height: 1.6;color: rgb(255, 41, 65);\"><\/span><\/p>\n<section class=\"\"  style=\"font-size: 16px;line-height: 25.6px;white-space: normal;max-width: 100%;box-sizing: border-box;color: rgb(62, 62, 62);word-wrap: break-word !important;\">\n<section class=\"\" style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"padding: 10px;max-width: 100%;box-sizing: border-box;border: 0.8em solid;-webkit-border-image: url(&quot;https:\/\/mmbiz.qpic.cn\/mmbiz_png\/eDotHGpLa9iaVykicX5tjlhGZ5jW3oibriaF82BicV2NNj6Plb10qgnQxMbla2HOAjibV5lOeNW4RqjYShjEuZnAg3bQ\/640?wx_fmt=png&quot;) 54 fill;word-wrap: break-word !important;\">\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;text-align: center;word-wrap: break-word !important;\">\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box;color: rgb(166, 91, 203);word-wrap: break-word !important;background-color: rgb(255, 202, 0);\">\u62a5\u540d\u54a8\u8be2\uff1a<\/span><\/strong><strong style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box;color: rgb(166, 91, 203);word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 18px;background-color: rgb(255, 169, 0);\"><\/span><\/span><\/strong><\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box;color: rgb(166, 91, 203);word-wrap: break-word !important;background-color: rgb(255, 202, 0);\">\u57f9\u8bad\u4e2d\u5fc3\u8d1f\u8d23\u4eba\uff1a<\/span><\/strong><\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;\">\u674e\u5a1f13641150050<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;\">\u5fae\u4fe1QQ\u54a8\u8be2; 2736812589&nbsp;&nbsp;<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;\">\u611f\u5174\u8da3\u7684\u670b\u53cb\u5c3d\u5feb\u843d\u5b9e\u4e00\u4e0b\u4eba\u5458<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;\"><span style=\"color: rgb(255, 41, 65);\">\u7ec4\u56e2\u62a5\u540d\u53ef\u4eab\u53d7\u4f18\u60e0 \u6b22\u8fce\u54a8\u8be2\u62a5\u540d<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<p style=\"line-height: 25.6px;white-space: normal;\"><br  \/><\/p>\n<section class=\"\" style=\"padding-right: 5px;line-height: 25.6px;white-space: normal;display: inline-block;vertical-align: top;width: 156.234px;box-sizing: border-box;background-color: rgb(255, 255, 255);\">\n<section class=\"Powered-by-XIUMI V5\"  style=\"box-sizing: border-box;\">\n<section class=\"\" style=\"margin-top: 10px;margin-bottom: 10px;text-align: center;box-sizing: border-box;\"><br  \/><\/section>\n<\/section>\n<\/section>\n<section class=\"\" style=\"padding-right: 5px;line-height: 25.6px;white-space: normal;display: inline-block;vertical-align: top;width: 396.172px;box-sizing: border-box;background-color: rgb(255, 255, 255);\">\n<section class=\"Powered-by-XIUMI V5\"  style=\"box-sizing: border-box;\">\n<section class=\"\" style=\"margin-top: 25px;margin-bottom: 10px;text-align: center;box-sizing: border-box;\">\n<section class=\"\" style=\"display: inline-block;border: 6px solid rgb(217, 121, 47);border-radius: 0.5em;box-sizing: border-box;background-color: rgb(254, 255, 255);\">\n<section class=\"\" style=\"margin: -6px 8px;border-top-width: 8px;border-top-style: solid;border-top-color: rgb(255, 255, 255);border-bottom-width: 8px;border-bottom-style: solid;border-bottom-color: rgb(255, 255, 255);box-sizing: border-box;\">\n<section class=\"Powered-by-XIUMI V5\"  style=\"box-sizing: border-box;\">\n<section class=\"\" style=\"box-sizing: border-box;\">\n<section class=\"\" style=\"text-align: left;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">\u70b9\u51fb\u9605\u8bfb\u539f\u6587\uff0c\u8df3\u8f6c\u81f3\u62a5\u540d\u8868\u5355<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section><\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u70b9\u51fb\u2191\u836f\u7814\u6280\u672f\u6c47\u5728\u7ebf\u5173\u6ce8 \u5e8f\u53f7\uff1a1 \u3000\u3000\u7f3a\u9677\u5173\u952e\u8bcd\uff1a\u6570\u636e\u53ef\u9760\u6027\uff0c\u6279\u8bb0\u5f55 \u3000\u3000\u6765\u6e90\uff1aFDA\u8b66\u544a\u4fe1 \u3000\u3000\u53d1\u5e03\u65e5\u671f\uff1a [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":54154,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/54153"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=54153"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/54153\/revisions"}],"predecessor-version":[{"id":54158,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/54153\/revisions\/54158"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/54154"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=54153"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=54153"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=54153"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}