{"id":81661,"date":"2019-03-19T00:00:50","date_gmt":"2019-04-11T06:51:35","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/81661\/"},"modified":"2019-04-11T14:51:36","modified_gmt":"2019-04-11T06:51:36","slug":"53057997e3","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/81661\/","title":{"rendered":"\u3010\u8b66\u544a\u4fe1\u3011320-19-14\u8f89\u745e\u5370\u5ea6\u5de5\u5382\u7f3a\u9677\u5206\u6790"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<h2 style=\"margin-bottom: 14px;font-size: 22px;max-width: 100%;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;line-height: 1.4;text-align: start;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA\u4e8e2018.03.27-04.03\uff0c\u7531\u68c0\u5bdf\u5b98Jose E Melendez\u548cAdemola O Daramola,&nbsp;<\/span><span style=\"max-width: 100%;color: rgb(172, 57, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u5bf9\u8f89\u745eHospira Healthcare India Pvt.Ltd\u5728\u5370\u5ea6Tamil Nadu\u7684Sriperrumbudur\u5de5\u5382\u8fdb\u884c\u4e86\u4e3a\u671f\u516d\u5929\uff0c\u5171\u5f00\u51fa\u4e8632\u987511\u6761\u7f3a\u9677\u3002<\/span><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/span><\/h2>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;max-width: 100%;color: rgb(172, 57, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u8fd1\u65e5\uff0cFDA\u5b98\u7f51\u6302\u51fa\u9488\u5bf9\u6b64\u5de5\u5382\u7684\u8b66\u544a\u4fe1\uff0c\u8b66\u544a\u4fe1\u4e2d\u53ef\u4ee5\u770b\u51fa\uff0cFDA\u5bf9\u4e8eQC\u7684\u68c0\u9a8c\u6570\u636e\u8868\u793a\u5f88\u62c5\u5fe7\u3002\u8be5\u7f3a\u9677\u5305\u62ec\u5982\u4e0b\uff1a<\/span><\/strong><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/span><\/p>\n<section style=\"max-width: 100%;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\n<section  style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(171, 25, 66);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5fae\u751f\u7269\u5b9e\u9a8c\u5ba4\u6570\u636e\u5b8c\u6574\u6027\uff1a<\/strong><\/span><\/p>\n<ul class=\"list-paddingleft-2\" style=\"\">\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4eba\u5458\u548c\u73af\u5883\u76d1\u6d4b\u57f9\u517b\u57fa\u7ed3\u679c\u4e0e\u5b9e\u9645\u4e0d\u7b26\uff0c\u660e\u663e\u5c11\u62a5\u3002\u68c0\u67e5\u5458\u53d1\u73b0\u57f9\u517b\u57fa\u5b9e\u7269\u83cc\u843d\u6570\u4e0e\u8bb0\u5f55\u6570\u4e0d\u4e00\u81f4\uff0c\u540e\u8be5\u516c\u53f8\u5458\u5de5\u627f\u8ba4\u8be5\u4e25\u91cd\u9519\u8bef\u3002\u8be5\u516c\u53f8\u540e\u6574\u6539\u4e3a\u5b9e\u9645\u8ba1\u6570\u7ed3\u679c\uff0c\u4f46\u53d1\u73b0\u73af\u5883\u76d1\u6d4b\u7ed3\u679c\u6025\u5267\u589e\u52a0\u3002<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA\u8bc4\u8bba\u8be5\u5382\u5fae\u751f\u7269\u6570\u636e\u5b8c\u6574\u6027\u95ee\u9898\u4f7f\u5f97\u8be5\u5382\u653e\u884c\u7684\u836f\u54c1\u7684\u65e0\u83cc\u6027\u65e0\u6cd5\u4fdd\u8bc1\u3002<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA\u540c\u65f6\u5bf9\u8be5\u5382QC\u5b9e\u9a8c\u5ba4\u62a5\u544a\u7684\u6240\u6709\u7ed3\u679c\u7684\u6709\u6548\u6027\u7684\u8868\u793a\u4e25\u91cd\u62c5\u5fe7\u3002<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5c3d\u7ba1\u8f89\u745e\u9ad8\u5c42\u5728FDA\u76d1\u7ba1\u4f1a\u8bae\u4e0a\u518d\u6b21\u4e0eFDA\u6c9f\u901a\u8be5\u6570\u636e\u5b8c\u6574\u6027\u7684\u6574\u6539\u95ee\u9898\uff0c\u4f46\u662fFDA\u8868\u793a\uff0c\u8be5\u516c\u53f8\u5c1a\u6ca1\u6709\u8bf4\u660e\u6570\u636e\u62a5\u544a\u4e0d\u51c6\u786e\u7684\u8303\u56f4, \u4ee5\u53ca\u7ba1\u7406\u5c42\u548c\u5458\u5de5\u53c2\u4e0e\u6570\u636e\u9020\u5047\u7684\u7a0b\u5ea6\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<\/li>\n<\/ul>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;\"><strong style=\"max-width: 100%;color: rgb(171, 25, 66);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5de5\u827a\u63a7\u5236\u4e0d\u8db3\uff1a<\/span><\/strong><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/span><\/p>\n<ul class=\"list-paddingleft-2\" style=\"\">\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA\u68c0\u67e5\u4e86\u8be5\u5382\u706f\u68c0\u4e0d\u826f\u60c5\u51b5\uff0c\u53d1\u73b0\u591a\u4e2a\u6279\u6b21\u706f\u68c0\u5173\u952e\u7f3a\u9677\u4e0d\u826f\u8d85\u51fa\u89c4\u5b9a\u7684\u9650\u5ea6\u3002<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5728\u5bf9\u8be5\u5382\u7684\u7559\u6837\u7684\u68c0\u67e5\u671f\u95f4\uff0cFDA\u518d\u6b21\u53d1\u73b0\u4e86\u591a\u4e2a\u5916\u89c2\u7f3a\u9677\u6837\u54c1\u3002<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA\u8bc4\u8bba\u8be5\u5382\u5de5\u827a\u5bf9\u706f\u68c0\u5173\u952e\u7f3a\u9677\u7684\u5bb9\u5fcd\u5ea6\u8fc7\u9ad8\uff0c\u8d28\u91cf\u90e8\u95e8\u672a\u80fd\u53ca\u65f6\u53d1\u73b0\u751f\u4ea7\u7684\u4e0d\u826f\u4fe1\u606f\uff0c\u4f7f\u5f97\u51e0\u6279\u6709\u5173\u952e\u8d28\u91cf\u7f3a\u9677\u7684\u836f\u54c1\u8fdb\u5165\u5e02\u573a\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(171, 25, 66);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5316\u5b66\u5b9e\u9a8c\u5ba4\u6570\u636e\u5b8c\u6574\u6027\uff1a<\/strong><\/span><\/p>\n<ul class=\"list-paddingleft-2\" style=\"\">\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA\u5bf9\u51e0\u4e2a\u5df2\u7ecf\u68c0\u9a8c\u5408\u683c\u7684\u6279\u6b21\u8981\u6c42\u5f53\u573a\u8fdb\u884c\u590d\u6d4b\uff0c\u7ed3\u679c\u5747\u4e3aOOS\u3002<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA\u53d1\u73b0\u8be5\u5382\u68c0\u9a8c\u5458\u6ca1\u6709\u7528\u4ee5\u8bb0\u5f55\u65f6\u95f4\u7684\u65f6\u949f\u3002<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA\u8868\u793a\u8be5\u5382\u672a\u786e\u5b9a\u5728\u76f8\u540c\u5b9e\u9a8c\u5ba4\u8fdb\u884c\u7684\u5176\u5b83QC\u5b9e\u9a8c\u5ba4\u68c0\u9a8c\u662f\u5426\u53d7\u6570\u636e\u5b8c\u6574\u6027\u95ee\u9898\u5f71\u54cd\uff0c\u4e5f\u672a\u8ba8\u8bba\u5de5\u5382\u5185\u6570\u636e\u5b8c\u6574\u6027\u95ee\u9898\u7684\u7a0b\u5ea6\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><mpcpc js_editor_cpcad=\"\" class=\"js_cpc_area res_iframe cpc_iframe\" src=\"\/cgi-bin\/readtemplate?t=tmpl\/cpc_tmpl#1552956562827\" data-category_id_list=\"11|22|28|31|32|36|43|44|48|6|8\" ><\/mpcpc><\/p>\n<p style=\"max-width: 100%;min-height: 1em;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;max-width: 100%;color: rgb(172, 57, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e3a\u4e86\u4fbf\u4e8e\u5927\u5bb6\u7406\u89e3\uff0c\u8fd9\u91cc\u5c062018\u5e74\u6b64\u6b21\u68c0\u67e5\u7684483\u7f3a\u9677\u8fdb\u884c\u5217\u4e3e\uff0c\uff08\u517111\u6761\uff09\u3002\u4e3b\u8981\u95ee\u9898\u56f4\u7ed5\u5728\uff1a<\/span><\/strong><\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(171, 25, 66);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8d28\u91cf\u4f53\u7cfb\uff1a\u8d28\u91cf\u76d1\u7ba1\u4e0d\u8db3\uff1a<\/strong><\/span><\/p>\n<ul class=\"list-paddingleft-2\" style=\"\">\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;max-width: 100%;color: rgb(0, 128, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u8d28\u91cf\u90e8\u95e8\u4e0d\u80fd\u786e\u4fdd\u6240\u6709\u7684\u751f\u4ea7\u548c\u5b9e\u9a8c\u5ba4\u64cd\u4f5c\u7b26\u5408cGMP\u8981\u6c42<\/span><\/strong><span style=\"font-size: 14px;max-width: 100%;color: rgb(0, 128, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u3002\u5728FDA\u68c0\u67e5\u8fc7\u7a0b\u4e2d\u53d1\u73b0\u7684\u6240\u6709\u7f3a\u9677\u90fd\u8868\u660e\u4e86\u8d28\u91cf\u90e8\u95e8\u6ca1\u6709\u91c7\u53d6\u5fc5\u8981\u63aa\u65bd\u4ee5\u786e\u4fdd\u5145\u5206\u5f00\u5c55\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\/\u8f6c\u79fb\uff0c\u6ca1\u6709\u5206\u6790\u7ed3\u679c\u51c6\u786e\u6027\u4ee5\u53ca\u5bf9\u751f\u4ea7\u6216\u68c0\u6d4b\u8fc7\u7a0b\u4e2d\u53d1\u751f\u7684\u6240\u6709\u4e8b\u4ef6\u8fdb\u884c\u4e86\u6070\u5f53\u7684\u8c03\u67e5\u3002\u6b64\u5916\uff0c\u6587\u4ef6\u4e2d\u51fa\u73b0\u7684\u8bb8\u591a\u4e0d\u53ef\u63a5\u53d7\u60c5\u51b5\u8868\u660e\u4eba\u5458\u5bf9\u786e\u4fddcGMP\u6570\u636e\u5b8c\u6574\u6027\u7684\u91cd\u8981\u6027\u8ba4\u77e5\u4e0d\u8db3\u3002\uff08<\/span><span style=\"font-size: 14px;max-width: 100%;color: rgb(171, 25, 66);box-sizing: border-box !important;word-wrap: break-word !important;\">2016\u5e74\u68c0\u67e5\u7684\u91cd\u590d\u7f3a\u9677<\/span><span style=\"font-size: 14px;max-width: 100%;color: rgb(0, 128, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09<\/span><\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u516c\u53f8\u5728\u63a5\u6536\u5230\u4e00\u6279\u6216\u591a\u6279\u67d0\u4e2a\u4ea7\u54c1\u4e0a\u5e02\u6279\u6b21\u4e0d\u7b26\u5408\u6ce8\u518c\u8d28\u91cf\u6807\u51c6\u7684\u4fe1\u606f\u540e\u4e09\u4e2a\u5de5\u4f5c\u65e5\u5185\u6ca1\u6709\u9012\u4ea4XXX\u73b0\u573a\u8b66\u62a5\u62a5\u544a\uff08FAR\uff09<\/span><\/p>\n<\/li>\n<\/ul>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(171, 25, 66);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5b9e\u9a8c\u5ba4\u63a7\u5236\u7cfb\u7edf\uff1a\u5b9e\u9a8c\u5ba4\u6570\u636e\u4e0d\u53ef\u9760\u3001\u5f02\u5e38\u8c03\u67e5\u4e0d\u5168\u9762<\/strong><\/span><\/p>\n<ul class=\"list-paddingleft-2\" style=\"\">\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5b9e\u9a8c\u5ba4\u8bb0\u5f55\u6ca1\u6709\u5305\u542b\u6240\u6709\u6d4b\u8bd5\u3001\u5b9e\u9a8c\u548c\u542b\u91cf\u68c0\u6d4b\u4e2d\u83b7\u5f97\u7684\u5b8c\u6574\u6570\u636e\uff0c\u4ee5\u786e\u4fdd\u4ea7\u54c1\u7b26\u5408\u5df2\u5efa\u7acb\u7684\u89c4\u683c\u6807\u51c6\u3002<strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5fae\u751f\u7269\u5b9e\u9a8c\u5ba4\u6570\u636e\u4e0d\u53ef\u9760<\/strong>\uff0c\u5728\u516c\u53f8\u5b9e\u9a8c\u5ba4\u53d7\u63a7\u7684\u5b9e\u9a8c\u5ba4\u8bb0\u5f55\u4e2d\u8bb0\u5f55\u7684\u5fae\u751f\u7269\u751f\u957f\u8ba1\u6570\u4e0e\u57f9\u517b\u57fa\u789f\u4e2d\u89c2\u5bdf\u5230\u7684\u5b9e\u9645\u8ba1\u6570\u4e0d\u4e00\u81f4\uff1b<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5bf9\u4e0a\u5e02\u836f\u54c1\u7684\u68c0\u6d4b\u548c\u653e\u884c\u6ca1\u6709\u5305\u62ec\u5b9e\u9a8c\u5ba4\u5bf9\u4e8e\u5236\u5242\u4ea7\u54c1\u4e0e\u6700\u7ec8\u8d28\u91cf\u6807\u51c6\u3001\u6bcf\u4e2a\u6d3b\u6027\u6210\u5206\u7684\u5242\u91cf\u548c\u9274\u522b\u7b26\u5408\u4e00\u81f4\u7684\u653e\u884c\u51b3\u5b9a\u3002\u516c\u53f8\u8d28\u91cf\u63a7\u5236\u90e8\u5316\u5b66<strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u68c0\u6d4b\u4eba\u5458\u7be1\u6539\u68c0\u6d4b\u6837\u54c1\u91cd\u91cf<\/strong>\u4ece\u800c\u4f7f\u591a\u6279XX\u6ce8\u5c04\u5242USP\u539f\u6599\u836f\u548c\u5236\u5242\u6210\u54c1\u901a\u8fc7XX\u68c0\u6d4b\u3002<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;\"><span style=\"font-size: 14px;max-width: 100%;color: rgb(0, 128, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u65e0\u8bba\u4ea7\u54c1\u662f\u5426\u88ab\u9500\u552e\uff0c\u516c\u53f8\u90fd<strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6ca1\u6709\u5bf9\u4efb\u4f55\u539f\u56e0\u4e0d\u660e\u7684\u504f\u5dee\u3001\u4ea7\u54c1\u4e0d\u5408\u683c\u6216\u5176\u4efb\u610f\u6210\u5206\u4e0d\u7b26\u5408\u8d28\u91cf\u6807\u51c6\u7684\u6295\u8bc9\u7b49\u60c5\u51b5\u8fdb\u884c\u5168\u9762\u5ba1\u6838\u548c\u8c03\u67e5<\/strong>\u3002\uff08<\/span><span style=\"font-size: 14px;max-width: 100%;color: rgb(171, 25, 66);box-sizing: border-box !important;word-wrap: break-word !important;\">2016\u5e74\u68c0\u67e5\u7684\u91cd\u590d\u7f3a\u9677<\/span><span style=\"font-size: 14px;max-width: 100%;color: rgb(0, 128, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09<\/span><\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5bf9\u4e8e\u539f\u56e0\u4e0d\u660e\u7684\u504f\u5dee\uff0c\u6210\u54c1\u4e0d\u5408\u683c\u6216\u5176\u7ec4\u5206\u4e0d\u7b26\u5408\u8d28\u91cf\u6807\u51c6\u7684\u4e66\u9762\u8c03\u67e5\u8bb0\u5f55\u5e76\u4e0d\u662f\u90fd\u6709\u7ed3\u8bba\u548c\u8fdb\u4e00\u6b65\u884c\u52a8\u3002<strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u65e0\u6cd5\u786e\u4fdd\u516c\u53f8\u5f00\u5c55\u7684\u8c03\u67e5\u90fd\u4f1a\u5305\u542b\u5bf9\u504f\u5dee\u7684\u5168\u9762\u8bc4\u4f30\uff0c\u91c7\u7528\u9002\u5f53\u7684\u79d1\u5b66\u5206\u6790\u65b9\u6cd5\u6765\u67e5\u627e\u5230\u53ef\u80fd\u7684\u6839\u672c\u539f\u56e0\u3002<\/strong>\u7ecf\u7531\u6b64\u7c7b\u8c03\u67e5\u63d0\u51fa\u7684\u7ea0\u6b63\u9884\u9632\u63aa\u65bd\uff0c\u4e5f\u5e76\u4e0d\u8db3\u4ee5\u6216\u5e76\u4e0d\u80fd\u6070\u5f53\u5730\u5904\u7406\u786e\u5b9a\u7684\u504f\u5dee\uff0c\u4e14\u672a\u80fd\u53ca\u65f6\u91c7\u53d6\u8fdb\u4e00\u6b65\u9884\u9632\u63aa\u65bd\u3002<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;max-width: 100%;color: rgb(0, 128, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u6ca1\u6709\u5efa\u7acb\u548c\u8bb0\u5f55\u5206\u6790\u65b9\u6cd5\u51c6\u786e\u6027\u3001\u7075\u654f\u6027\u3001\u4e13\u5c5e\u6027\u548c\u91cd\u73b0\u6027\u3002\u5236\u5242\u6210\u54c1\u7f3a\u4e4f\u7a33\u5b9a\u6027\u6307\u5f81\u7684\u6d4b\u8bd5\u65b9\u6cd5<\/span><\/strong><span style=\"font-size: 14px;max-width: 100%;color: rgb(0, 128, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c\u56e0\u6b64\uff0c\u65e0\u6cd5\u4fdd\u8bc1\u4f7f\u7528\u5206\u6790\u65b9\u6cd5\u4ea7\u751f\u7684\u6570\u636e\u548c\u7ed3\u679c\u7684\u53ef\u9760\u6027\u3002<\/span><\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;max-width: 100%;color: rgb(0, 128, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u4eea\u5668\u6ca1\u6709\u6309\u7167\u516c\u53f8\u6587\u4ef6\u89c4\u5b9a\u7684\u9002\u5f53\u5468\u671f\u6821\u9a8c<\/span><\/strong><span style=\"font-size: 14px;max-width: 100%;color: rgb(0, 128, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\uff0c\u6587\u4ef6\u89c4\u5b9a\u51fa\u73b0\u51c6\u786e\u6027\u548c\/\u6216\u7cbe\u786e\u6027\u9650\u5ea6\u95ee\u9898\u65f6\u7684\u8865\u6551\u63aa\u65bd\u4e5f\u6ca1\u6709\u6267\u884c\u3002<\/span><\/span><\/p>\n<\/li>\n<\/ul>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(171, 25, 66);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u751f\u4ea7\u7cfb\u7edf\uff1a\u5de5\u827a\u63a7\u5236\u4e0d\u8db3<\/strong><\/span><\/p>\n<ul class=\"list-paddingleft-2\" style=\"\">\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;max-width: 100%;color: rgb(0, 128, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u6ca1\u6709\u5efa\u7acb\u63a7\u5236\u7a0b\u5e8f\u6765\u76d1\u63a7\u5de5\u827a\u7684\u6536\u7387\u548c\u9a8c\u8bc1\u751f\u4ea7\u5de5\u827a\u7684\u6027\u80fd\uff0c<\/span><\/strong><span style=\"font-size: 14px;max-width: 100%;color: rgb(0, 128, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u800c\u8fd9\u4e9b\u90fd\u4f1a\u5f71\u54cd\u5230\u4e2d\u95f4\u4f53\u548c\u5236\u5242\u6210\u54c1\u7684\u6027\u8d28\u6ce2\u52a8\u548c\u6539\u53d8\u3002\u4e8b\u5b9e\u663e\u793a\u51fa\uff0c\u516c\u53f8\u7f3a\u4e4f\u4ec0\u4e48\u662f\u8db3\u591f\u7684\u8fc7\u7a0b\u63a7\u5236\u7684\u8ba4\u77e5\uff0c\u5176\u5305\u62ec\u5fc5\u8981\u7684\u5173\u952e\u5de5\u827a\u53c2\u6570\u7684\u8bc6\u522b\u548c\u754c\u5b9a\uff0c\u7528\u4e8e\u4fdd\u8bc1\u6210\u54c1\u8d28\u91cf\u548c\u52a0\u5f3a\u5bf9\u6ce8\u5c04\u5242\u751f\u4ea7\u8fc7\u7a0b\u4e00\u81f4\u6027\u7684\u5173\u6ce8\u3002<\/span><\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;max-width: 100%;color: rgb(0, 128, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u6ca1\u6709\u5efa\u7acb\u3001\u8bb0\u5f55\u548c\u6267\u884c\u9884\u9632\u65e0\u83cc\u836f\u54c1\u5fae\u751f\u7269\u6c61\u67d3\u7684\u7a0b\u5e8f<\/span><\/strong><span style=\"font-size: 14px;max-width: 100%;color: rgb(0, 128, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u3002\u65e0\u6cd5\u786e\u4fdd\u5f00\u5c55\u7684\u5de5\u827a\u6a21\u62df\u5b9e\u9a8c\uff08\u57f9\u517b\u57fa\u704c\u88c5\uff09\u80fd\u4ee3\u8868\u65e5\u5e38\u65e0\u83cc\u5c0f\u74f6\u704c\u88c5\u89c2\u5bdf\u5230\u7684\u548c\/\u6216\u53ef\u80fd\u53d1\u751f\u7684\u771f\u5b9e\u60c5\u51b5\u3002\u5b9e\u9645\u60c5\u51b5\u662f\u867d\u7136\u5728\u57f9\u517b\u57fa\u704c\u88c5\u8fc7\u7a0b\u4e2d\u64cd\u4f5c\u4eba\u5458\u7ea0\u6b63\u548c\u56fa\u6709\u5e72\u9884\u662f\u76f8\u4f3c\u7684\uff0c\u4f46\u662f\u6ca1\u6709\u660e\u786e\u89c4\u5b9a\u5e72\u9884\u9891\u6b21\u548c\u6301\u7eed\u65f6\u95f4\u3002\uff08<\/span><span style=\"font-size: 14px;max-width: 100%;color: rgb(171, 25, 66);box-sizing: border-box !important;word-wrap: break-word !important;\">\u6b64\u7c7b\u95ee\u9898\u662f\u7b2c\u4e94\u6b21\u91cd\u590d\u53d1\u751f\u4e86<\/span><span style=\"font-size: 14px;max-width: 100%;color: rgb(0, 128, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09<\/span><\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;max-width: 100%;color: rgb(0, 128, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u5728\u751f\u4ea7\u64cd\u4f5c\u548c\u8fc7\u7a0b\u63a7\u5236\u4e2d\u6ca1\u6709\u6309\u7167\u4e66\u9762\u7684\u751f\u4ea7\u548c\u8fc7\u7a0b\u63a7\u5236\u7a0b\u5e8f\u89c4\u5b9a\u5f00\u5c55\u5de5\u4f5c\u5e76\u53ca\u65f6\u8bb0\u5f55\u3002<\/span><\/strong><\/span><\/p>\n<\/li>\n<\/ul>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><mpcpc js_editor_cpcad=\"\" class=\"js_cpc_area res_iframe cpc_iframe\" src=\"\/cgi-bin\/readtemplate?t=tmpl\/cpc_tmpl#1552956573715\" data-category_id_list=\"11|22|28|31|32|36|43|44|48|6|8\" ><\/mpcpc><\/p>\n<p style=\"max-width: 100%;min-height: 1em;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;\"><img class=\"__bg_gif\"      style=\"box-sizing: border-box !important;word-wrap: break-word !important;width: 78px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/04\/8-1554965496.gif\" alt=\"\u3010\u8b66\u544a\u4fe1\u3011320-19-14\u8f89\u745e\u5370\u5ea6\u5de5\u5382\u7f3a\u9677\u5206\u6790\" title=\"\u3010\u8b66\u544a\u4fe1\u3011320-19-14\u8f89\u745e\u5370\u5ea6\u5de5\u5382\u7f3a\u9677\u5206\u6790\"  \/><\/p>\n<h2 style=\"margin-bottom: 14px;font-size: 22px;max-width: 100%;line-height: 1.4;letter-spacing: 0.544px;text-align: start;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;color: rgb(64, 118, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;text-decoration: underline;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><a href=\"http:\/\/mp.weixin.qq.com\/s?__biz=MzU1MTc2NDM5Ng==&amp;mid=2247483689&amp;idx=1&amp;sn=9f582e819be505137901ec344e9836eb&amp;chksm=fb8d29eaccfaa0fcc2434608923ba12445d75d30beddbb2b18880aabf2543aac0c2738899269&amp;scene=21#wechat_redirect\" target=\"_blank\"   style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;color: rgb(64, 118, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;text-decoration: underline;\">2018.03.27-04.03 \u8f89\u745eHospira 483\u8868&nbsp; \u7ffb\u8bd1\u5206\u6790<\/a><\/strong><\/span><\/h2>\n<p style=\"max-width: 100%;min-height: 1em;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;\"><img class=\"__bg_gif\"      style=\"box-sizing: border-box !important;word-wrap: break-word !important;width: 78px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/04\/2-1554965496.gif\" alt=\"\u3010\u8b66\u544a\u4fe1\u3011320-19-14\u8f89\u745e\u5370\u5ea6\u5de5\u5382\u7f3a\u9677\u5206\u6790\" title=\"\u3010\u8b66\u544a\u4fe1\u3011320-19-14\u8f89\u745e\u5370\u5ea6\u5de5\u5382\u7f3a\u9677\u5206\u6790\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(64, 118, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">2019.03.12 \u8f89\u745e<span style=\"color: rgb(64, 118, 0);font-size: 14px;max-width: 100%;letter-spacing: 0.544px;text-align: start;\">Hospira \u8b66\u544a\u4fe1 \u7ffb\u8bd1\uff1a<\/span><\/span><span style=\"letter-spacing: 0.544px;text-align: start;max-width: 100%;color: rgb(64, 118, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\"><a href=\"http:\/\/mp.weixin.qq.com\/s?__biz=MzA5Mzk5NzE1MA==&amp;mid=2651712054&amp;idx=1&amp;sn=3532be85cdf11b4b64123f45eaf41aed&amp;chksm=8bac1b07bcdb92119ea423dae8e9e1229137f51c4b74dc937577f7d03970309a1dcfa14f3959&amp;scene=21#wechat_redirect\" target=\"_blank\"   style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8f6c\u81ea&nbsp;GMP\u529e\u516c\u5ba4<\/a><\/span><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br  \/><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">Warning Letter 320-19-14 &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;March 4, 2019<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">Mr. Albert Bourla, Chairman and Chief Executive Officer<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">Mr. Albert Bourla,\u4e3b\u5e2d\u517c\u9996\u5e2d\u6267\u884c\u5b98<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">Worldwide Pfizer, 235E 42nd St., New York, NY 10017<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7ebd\u7ea6\u8f89\u745e\u603b\u90e8<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">Dear Mr. Bourla:<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hospira Healthcare India Pvt. Ltd.,at Plots B3, B4, B5 (pt); B6 (pt); B11-B18 and B21-B23, SIPCOT Industrial Park,Irungattukottai, Sriperumbudur, Kancheepuram District, Tamil Nadu, India, from March 27 to April 3, 2018.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7f8e\u56fdFDA\u4e8e2018\u5e743\u670827\u65e5\u81f34\u67083\u65e5\u68c0\u67e5\u4e86\u4f60\u4eec\u4f4d\u4e8e\u5370\u5ea6\u7684Hospira Healthcare India Pvt.Ltd.\u751f\u4ea7\u573a\u6240\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u672c\u8b66\u544a\u4fe1\u603b\u7ed3\u4e86\u5236\u5242\u751f\u4ea7\u4e25\u91cd\u8fdd\u53cdCGMP\u7684\u884c\u4e3a\u3002\u53c2\u89c121CFR\u7b2c210\u4e0e211\u90e8\u5206\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&amp;C Act), 21 U.S.C. 351(a)(2)(B).<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7531\u4e8e\u4f60\u4eec\u7684\u5236\u5242\u751f\u4ea7\u3001\u52a0\u5de5\u3001\u5305\u88c5\u6216\u4fdd\u5b58\u7684\u65b9\u6cd5\u3001\u573a\u6240\u6216\u63a7\u5236\u4e0d\u7b26\u5408CGMP\u8981\u6c42\uff0c\u4f60\u4eec\u7684\u836f\u54c1\u6839\u636eFDCA\u7684501(a)(2)(B)\u4ee5\u53ca21 U.S.C. 351(a)(2)(B)\u88ab\u8ba4\u4e3a\u63ba\u5047\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">We reviewed your April 24, 2018, response in detail and acknowledge receipt of subsequent correspondence.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6211\u4eec\u5df2\u8be6\u7ec6\u5ba1\u6838\u4e86\u4f60\u516c\u53f82018\u5e744\u670824\u65e5\u7684\u56de\u590d\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">During our inspection, our investigators observed specific violations including, but not limited to, the following.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u68c0\u67e5\u671f\u95f4\uff0c\u6211\u4eec\u7684\u68c0\u67e5\u4eba\u5458\u53d1\u73b0\u7684\u5177\u4f53\u95ee\u9898\u5305\u62ec\u4f46\u4e0d\u4ec5\u9650\u4e8e\u4ee5\u4e0b\uff1a<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">1. &nbsp; &nbsp;Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).<\/span><\/strong><\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8d35\u516c\u53f8\u672a\u80fd\u786e\u4fdd\u5b9e\u9a8c\u5ba4\u8bb0\u5f55\u5305\u542b\u4ece\u6240\u6709\u7528\u4ee5\u786e\u4fdd\u7b26\u5408\u65e2\u5b9a\u6807\u51c6\u7684\u6d4b\u8bd5\u4e2d\u83b7\u5f97\u7684\u5b8c\u6574\u6570\u636e(21 cfr 211.194(a))\u3002<\/span><\/strong><\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">Your microbiology laboratory did not accurately report test results. On March 27, 2018, during a walk-through of your laboratory, our investigator observed microbial growth on (b)(4) personnel\/environmental monitoring media plates associated with (b)(4) aseptic processing lines. However, our review of laboratory records found that analysts had recorded a result of \u201cNil\u201d (no growth) for each of these plates. On the same day, our investigator also observed that your microbiologist had significantly underreported microbial results for three (b)(4) samples.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4f60\u4eec\u7684\u5fae\u751f\u7269\u5b9e\u9a8c\u5ba4\u6ca1\u6709\u51c6\u786e\u5730\u62a5\u544a\u68c0\u9a8c\u7ed3\u679c\u30022018\u5e743\u670827\u65e5, \u5728\u4f60\u4eec\u7684\u5b9e\u9a8c\u5ba4\u68c0\u67e5\u8fc7\u7a0b\u4e2d, \u6211\u4eec\u7684\u68c0\u67e5\u4eba\u5458\u53d1\u73b0\u4e86\u4e0e (b)(4) \u65e0\u83cc\u751f\u4ea7\u7ebf\u76f8\u5173\u7684 (b)(4) \u4eba\u5458\u73af\u5883\u76d1\u6d4b\u57f9\u517b\u57fa\u789f\u4e0a\u6709\u5fae\u751f\u7269\u751f\u957f\u3002\u7136\u800c, \u6211\u4eec\u5bf9\u5b9e\u9a8c\u5ba4\u8bb0\u5f55\u7684\u5ba1\u67e5\u53d1\u73b0, \u5206\u6790\u4eba\u5458\u5bf9\u8fd9\u4e9b\u789f\u5b50\u8bb0\u5f55\u7684\u7ed3\u679c\u4e3a&#8221;\u96f6&#8221; (\u65e0\u751f\u957f)\u3002\u540c\u4e00\u5929, \u6211\u4eec\u7684\u68c0\u67e5\u4eba\u5458\u8fd8\u53d1\u73b0\uff0c\u4f60\u7684\u5fae\u751f\u7269\u4eba\u5458\u5bf93\u4e2a (b)(4) \u6837\u54c1\u7684\u5fae\u751f\u7269\u7ed3\u679c\u660e\u663e\u5c11\u62a5\u3002<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">During the inspection, your staff confirmed that laboratory records did not accurately reflect the actual microbial growth observed on plates.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5728\u68c0\u67e5\u8fc7\u7a0b\u4e2d, \u4f60\u4eec\u5458\u5de5\u786e\u8ba4, \u5b9e\u9a8c\u5ba4\u8bb0\u5f55\u6ca1\u6709\u51c6\u786e\u53cd\u6620\u5728\u789f\u5b50\u4e0a\u89c2\u5bdf\u5230\u7684\u5b9e\u9645\u5fae\u751f\u7269\u7ed3\u679c\u3002<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">Your written response acknowledged the significance of these microbial growth count discrepancies. Your firm also stated that, after implementing extra plate-reading oversight in the microbiology laboratory, a notable increase in counts emerged in environmental monitoring results, with a particularly \u201csharp\u201d increase in personnel monitoring excursions across the facility.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4f60\u4eec\u7684\u4e66\u9762\u56de\u590d\u627f\u8ba4\u4e86\u8fd9\u4e9b\u5fae\u751f\u7269\u8ba1\u6570\u7684\u4e25\u91cd\u9519\u8bef\u3002\u8d35\u516c\u53f8\u8fd8\u8868\u793a, \u5728\u5bf9\u5fae\u751f\u7269\u8ba1\u6570\u5b9e\u65bd\u989d\u5916\u7684\u76d1\u7763\u540e, \u73af\u5883\u76d1\u6d4b\u7ed3\u679c\u51fa\u73b0\u4e86\u660e\u663e\u7684\u6570\u91cf\u5267\u589e, \u5c24\u5176\u662f\u6574\u4e2a\u5de5\u5382\u7684\u4eba\u5458\u76d1\u6d4b\u7ed3\u679c&#8221;\u6025\u5267&#8221;\u589e\u52a0\u3002<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">Accurate microbiological data is fundamental to evaluating and maintaining the state of control of an aseptic processing operation. Awareness of microbial excursions in an aseptic processing operation is essential to trigger prompt actions that maintain environment control. Your failure to report accurate data compromised the sterility assurance of drug products released from the facility and may have increased risks to patients.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u51c6\u786e\u7684\u5fae\u751f\u7269\u6570\u636e\u662f\u8bc4\u4f30\u548c\u4fdd\u6301\u65e0\u83cc\u5904\u7406\u64cd\u4f5c\u63a7\u5236\u72b6\u6001\u7684\u57fa\u7840\u3002\u5728\u65e0\u83cc\u5904\u7406\u64cd\u4f5c\u4e2d\u53d1\u73b0\u5fae\u751f\u7269\u504f\u79bb\u5bf9\u4e8e\u53ca\u65f6\u89e6\u53d1\u884c\u52a8\u7ef4\u6301\u73af\u5883\u63a7\u5236\u81f3\u5173\u91cd\u8981\u3002\u4f60\u4eec\u672a\u80fd\u62a5\u544a\u51c6\u786e\u6570\u636e\uff0c\u4f7f\u5f97\u4ece\u8be5\u5de5\u5382\u653e\u884c\u7684\u836f\u54c1\u7684\u65e0\u83cc\u6027\u65e0\u6cd5\u4fdd\u8bc1, \u5e76\u53ef\u80fd\u589e\u52a0\u60a3\u8005\u7684\u98ce\u9669\u3002<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">The critical data integrity breaches identified in our inspection also raise serious concerns regarding the validity of all results reported by your quality control laboratory. We acknowledge your decision during the inspection to suspend release of drug products until the data integrity issues were thoroughly investigated. We also note that during the FDA regulatory meeting held on May 8, 2018, your management further acknowledged the significant data integrity problem identified in the inspection and discussed a comprehensive plan to address root causes.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5728\u6211\u4eec\u7684\u68c0\u67e5\u4e2d\u53d1\u73b0\u7684\u4e25\u91cd\u6570\u636e\u5b8c\u6574\u6027\u95ee\u9898\u4e5f\u4f1a\u5f15\u53d1\u6211\u4eec\u5bf9\u4f60\u4eec\u7684QC\u5b9e\u9a8c\u5ba4\u62a5\u544a\u7684\u6240\u6709\u7ed3\u679c\u7684\u6709\u6548\u6027\u7684\u4e25\u91cd\u62c5\u5fe7\u3002\u68c0\u67e5\u671f\u95f4\u6211\u4eec\u6536\u5230\u4f60\u4eec\u6682\u505c\u653e\u884c\u836f\u54c1\u76f4\u5230\u6570\u636e\u5b8c\u6574\u6027\u95ee\u9898\u5f97\u5230\u5f7b\u5e95\u8c03\u67e5\u7684\u51b3\u5b9a\u3002\u6211\u4eec\u8fd8\u6ce8\u610f\u5230, \u57282018\u5e745\u67088\u65e5\u4e3e\u884c\u7684FDA\u76d1\u7ba1\u4f1a\u8bae\u4e0a, \u4f60\u4eec\u7684\u7ba1\u7406\u5c42\u8fdb\u4e00\u6b65\u8c08\u5230\u68c0\u67e5\u4e2d\u53d1\u73b0\u7684\u4e25\u91cd\u6570\u636e\u5b8c\u6574\u6027\u95ee\u9898, \u5e76\u8ba8\u8bba\u4e86\u89e3\u51b3\u6839\u672c\u539f\u56e0\u7684\u5168\u9762\u8ba1\u5212\u3002<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">Your response included adding corporate and third-party oversight of microbiology laboratory tests and data reporting, and several other remediation measures. However, your response did not describe the scope of inaccurate reporting of data, and the extent of management and staff involvement with data manipulation.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4f60\u4eec\u7684\u56de\u590d\u5305\u62ec\u589e\u52a0\u5bf9\u5fae\u751f\u7269\u5b9e\u9a8c\u5ba4\u6d4b\u8bd5\u548c\u6570\u636e\u62a5\u544a\u8fdb\u884c\u5185\u90e8\u548c\u7b2c\u4e09\u65b9\u76d1\u7763, \u4ee5\u53ca\u5176\u4ed6\u4e00\u4e9b\u8865\u6551\u63aa\u65bd\u3002\u7136\u800c, \u4f60\u4eec\u7684\u56de\u590d\u6ca1\u6709\u8bf4\u660e\u6570\u636e\u62a5\u544a\u4e0d\u51c6\u786e\u7684\u8303\u56f4, \u4ee5\u53ca\u7ba1\u7406\u5c42\u548c\u5458\u5de5\u53c2\u4e0e\u6570\u636e\u9020\u5047\u7684\u7a0b\u5ea6\u3002<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">In your response to this letter, include:<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u56de\u590d\u6b64\u51fd, \u8bf7\u5305\u62ec:<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">A final report on corrective actions and preventive actions (CAPA) that were implemented to assure that aseptic processing operations are maintained in a state of control, including fully requalifying personnel involved in these operations.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e00\u4efd\u4e3a\u786e\u4fdd\u65e0\u83cc\u64cd\u4f5c\u4fdd\u6301\u5728\u63a7\u5236\u72b6\u6001\u800c\u5b9e\u65bd\u7684\u7ea0\u6b63\u63aa\u65bd\u548c\u9884\u9632\u63aa\u65bd\u7684\u6700\u7ec8\u62a5\u544a\uff0c\u5305\u62ec\u5bf9\u53c2\u4e0e\u8fd9\u4e9b\u64cd\u4f5c\u7684\u4eba\u5458\u8fdb\u884c\u5168\u9762\u518d\u786e\u8ba4\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">The final report on changes implemented in the site\u2019s quality control (QC) laboratories to enhance procedures, training, and CGMP documentation practices observed during the inspection and as a result of post-inspection assessments.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5de5\u5382QC\u5b9e\u9a8c\u5ba4\u6240\u5b9e\u65bd\u7684\u7528\u4ee5\u5f3a\u5316\u7a0b\u5e8f\u3001\u57f9\u8bad\uff0c\u4ee5\u53ca\u9488\u5bf9\u68c0\u67e5\u671f\u95f4\u53d1\u73b0\u7684\u548c\u68c0\u67e5\u540e\u8bc4\u4f30\u53d1\u73b0\u7684CGMP\u6587\u4ef6\u8bb0\u5f55\u7f3a\u9677\u6240\u505a\u7684\u53d8\u66f4\u7684\u6700\u7ec8\u62a5\u544a\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">A comprehensive, retrospective review of reliability of all microbiology laboratory data, including but not limited to data relating to water system control and environmental monitoring (personnel, surfaces, air). Assess all batches within expiry and distributed in the United States.&nbsp;<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e00\u4efd\u5bf9\u6240\u6709\u5fae\u751f\u7269\u5b9e\u9a8c\u5ba4\u6570\u636e\u53ef\u9760\u6027\u8fdb\u884c\u5168\u9762\u56de\u987e\u5ba1\u6838\uff0c\u5305\u62ec\u4f46\u4e0d\u4ec5\u9650\u4e8e\u4e0e\u6c34\u7cfb\u7edf\u63a7\u5236\u548c\u73af\u5883\u76d1\u6d4b\uff08\u4eba\u5458\u3001\u8868\u9762\u3001\u7a7a\u6c14\uff09\u76f8\u5173\u7684\u6570\u636e\u3002\u8bc4\u4f30\u6240\u6709\u9500\u552e\u81f3\u7f8e\u56fd\u4ecd\u5728\u6548\u671f\u5185\u7684\u6279\u6b21\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">2. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).<\/span><\/strong><\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8d35\u516c\u53f8\u672a\u80fd\u5f7b\u5e95\u8c03\u67e5\u6240\u6709\u5df2\u9500\u552e\u548c\u672a\u9500\u552e\u6279\u6b21\u53ca\u5176\u7ec4\u5206\u7684\u504f\u5dee\u6216\u4e0d\u7b26\u5408\u5176\u8d28\u91cf\u6807\u51c6\u60c5\u51b5\uff0821 CFR 211.192\uff09\u3002<\/span><\/strong><\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">Your firm failed to adequately investigate poor control and critical defects in your (b)(4) manufacturing process.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8d35\u516c\u53f8\u672a\u80fd\u5145\u5206\u8c03\u67e5\u5728\u4f60\u4eecXX\u751f\u4ea7\u5de5\u827a\u4e2d\u7684\u4e0d\u826f\u63a7\u5236\u548c\u5173\u952e\u7f3a\u9677\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">Our inspection found that you initiated multiple investigations because batches exceeded critical defect limits for visual inspection. For example, during four months in 2017, three batches yielded excessive critical defect rates ranging from (b)(4)% to (b)(4)%. The limit is no more than (b)(4)%.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6211\u4eec\u7684\u68c0\u67e5\u53d1\u73b0\u7531\u4e8e\u6279\u6b21\u8d85\u51fa\u76ee\u89c6\u68c0\u67e5\u5173\u952e\u7f3a\u9677\u9650\u5ea6\uff0c\u4f60\u4eec\u53d1\u8d77\u4e86\u591a\u4e2a\u8c03\u67e5\u3002\u4f8b\u5982\uff0c\u57282017\u5e744\u4e2a\u6708\u95f4\uff0c\u67093\u6279\u5173\u952e\u7f3a\u9677\u7387\u8d85\u51fa\u8303\u56f4\uff08XX%-XX%\uff0c\u9650\u5ea6\u2264XX%\uff09\u3002<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">Manufacturing investigations indicated that high rates of significant (b)(4) appearance defects were caused by power failures and (b)(4) that disrupted the (b)(4). These events delayed reaching appropriate (b)(4) during the (b)(4), leading to insufficient and non-uniform (b)(4). However, your investigations did not sufficiently determine the root cause of recurring batches with significant (b)(4) defects when no power interruptions and cycle deviations were documented. Your process control problems permitted excessive (b)(4) to remain in finished product units and caused persistent defects. The (b)(4) caused by these (b)(4) process control difficulties were found to lead to quality attribute specification failures including impurities, assay, or (b)(4).<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u751f\u4ea7\u8c03\u67e5\u663e\u793a\u9ad8\u9891\u6b21\u4e25\u91cdXX\u5916\u89c2\u7f3a\u9677\u662f\u56e0\u4e3a\u65ad\u7535\u548cXX\u4e2d\u65ad\u5f15\u8d77\u7684\u3002\u8fd9\u4e9b\u4e8b\u4ef6\u5ef6\u8bef\u4e86\u5728XX\u671f\u95f4\u8fbe\u5230\u9002\u5f53\u7684XX\uff0c\u5bfc\u81f4XX\u4e0d\u8db3\u548c\u4e0d\u5747\u5300\u3002\u4f46\u662f\u4f60\u4eec\u7684\u8c03\u67e5\u5e76\u672a\u5145\u5206\u786e\u5b9a\u5728\u6ca1\u6709\u8bb0\u5f55\u4efb\u4f55\u65ad\u7535\u548c\u5faa\u73af\u504f\u5dee\u7684\u60c5\u51b5\u4e0b\uff0c\u6279\u6b21\u4ecd\u53cd\u590d\u51fa\u73b0\u4e25\u91cdXX\u7f3a\u9677\u7684\u6839\u672c\u539f\u56e0\u3002\u4f60\u4eec\u7684\u5de5\u827a\u63a7\u5236\u95ee\u9898\u5141\u8bb8\u5236\u5242\u5355\u5143\u4fdd\u6301\u8d85\u51faXX\uff0c\u5bfc\u81f4\u4e86\u6301\u7eed\u7f3a\u9677\u3002\u8fd9\u4e9bXX\u5de5\u827a\u63a7\u5236\u56f0\u96be\u5bfc\u81f4\u7684XX\u88ab\u53d1\u73b0\u4f1a\u5bfc\u81f4\u4e0d\u7b26\u5408\u8d28\u91cf\u5c5e\u6027\u6807\u51c6\uff0c\u5305\u62ec\u6742\u8d28\u3001\u542b\u91cf\u6216XX\u3002<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">The extent of these critical drug quality defects was further revealed when examination of reserve samples identified many (b)(4) appearance defects, although the lots had undergone the required 100% visual inspection and had met AQL sampling criteria.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5728\u68c0\u67e5\u7559\u6837\u65f6\u53d1\u73b0\u8bb8\u591aXX\u5916\u89c2\u7f3a\u9677\uff0c\u8fdb\u4e00\u6b65\u66b4\u9732\u4e86\u8fd9\u4e9b\u836f\u54c1\u5173\u952e\u8d28\u91cf\u7f3a\u9677\u7684\u7a0b\u5ea6\uff0c\u5c3d\u7ba1\u8fd9\u4e9b\u6279\u6b21\u7ecf\u8fc7\u4e86\u6240\u8981\u6c42\u7684100%\u706f\u68c0\u4e14\u7b26\u5408AQL\u53d6\u6837\u6807\u51c6\u3002<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">The investigations did not include a timely CAPA plan to address (b)(4) design deficiencies and inappropriately high tolerances for critical defects such as (b)(4). You also did not adequately address the need to highly scrutinize variances in pressure control in your (b)(4) equipment, including better triggers for investigation.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u68c0\u67e5\u5e76\u672a\u5305\u62ec\u53ca\u65f6\u7684CAPA\u8ba1\u5212\uff0c\u7528\u4ee5\u89e3\u51b3XX\u8bbe\u8ba1\u7f3a\u9677\u548c\u5173\u952e\u7f3a\u9677\uff08\u5982XX\uff09\u7684\u4e0d\u6070\u5f53\u7684\u8fc7\u9ad8\u7684\u5bb9\u5fcd\u5ea6\u3002\u4f60\u4eec\u4ea6\u672a\u8bf4\u660e\u662f\u5426\u9700\u8981\u5145\u5206\u4ed4\u7ec6\u68c0\u67e5\u5728\u4f60\u4eecXX\u8bbe\u5907\u7684\u538b\u529b\u63a7\u5236\u4e2d\u7684\u53d8\u91cf\uff0c\u5305\u62ec\u66f4\u597d\u5730\u89e6\u53d1\u8c03\u67e5\u3002<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">Excessive defects and major manufacturing deviations are both signals of unacceptable manufacturing variation and the need for thorough investigation into the sufficiency of process design and controls. The failure of your firm\u2019s operations and quality departments to promptly detect adverse signals in manufacturing permitted the conditions that allowed several batches with critical quality defects to be distributed.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8fc7\u591a\u7684\u7f3a\u9677\u548c\u4e3b\u8981\u751f\u4ea7\u504f\u5dee\u90fd\u662f\u4e0d\u53ef\u63a5\u53d7\u7684\u751f\u4ea7\u6ce2\u52a8\u7684\u4fe1\u53f7\uff0c\u9700\u8981\u5f7b\u5e95\u8c03\u67e5\u5de5\u827a\u8bbe\u8ba1\u548c\u63a7\u5236\u7684\u5145\u5206\u6027\u3002\u4f60\u4eec\u7684\u8fd0\u8425\u548c\u8d28\u91cf\u90e8\u95e8\u672a\u80fd\u53ca\u65f6\u53d1\u73b0\u751f\u4ea7\u7684\u4e0d\u826f\u4fe1\u606f\uff0c\u4f7f\u5f97\u51e0\u6279\u6709\u5173\u952e\u8d28\u91cf\u7f3a\u9677\u7684\u836f\u54c1\u8fdb\u5165\u5e02\u573a\u3002<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">We acknowledge your decision to recall all batches of (b)(4) injection USP (b)(4) and (b)(4) within expiry in the U.S. market, after your testing of retain samples showed subpotent test results.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6211\u4eec\u77e5\u6089\u4f60\u4eec\u5728\u68c0\u9a8c\u4e86\u7559\u6837\u5e76\u5f97\u5230\u6548\u4ef7\u8fc7\u4f4e\u7684\u68c0\u9a8c\u7ed3\u679c\u540e\uff0c\u51b3\u5b9a\u53ec\u56de\u6240\u6709\u9500\u552e\u81f3\u7f8e\u56fd\u5728\u6548\u671f\u5185\u7684XX\u6ce8\u5c04\u5242\u6279\u6b21\u3002<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">In your response, you committed to enhance process understanding and control. You stated that you would improve and validate a modified (b)(4) process and remediate deficiencies in the visual inspection program. Your response was inadequate in that:&nbsp;<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5728\u4f60\u4eec\u7684\u56de\u590d\u4e2d\uff0c\u4f60\u4eec\u627f\u8bfa\u4f1a\u52a0\u5f3a\u5de5\u827a\u7406\u89e3\u548c\u63a7\u5236\u3002\u4f60\u4eec\u8bf4\u4f60\u4eec\u4f1a\u6539\u8fdb\u548c\u9a8c\u8bc1\u4fee\u8ba2\u540e\u7684XX\u5de5\u827a\uff0c\u4fee\u590d\u76ee\u89c6\u68c0\u67e5\u7a0b\u5e8f\u7684\u7f3a\u9677\u3002\u4f60\u4eec\u7684\u56de\u590d\u5728\u4ee5\u4e0b\u65b9\u9762\u662f\u4e0d\u5145\u5206\u7684\uff1a<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">It did not include a reassessment of the adequacy of your CAPA to address handling out-of-specification (OOS) (b)(4) results obtained by your laboratory.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u672a\u5305\u62ec\u91cd\u65b0\u8bc4\u4f30\u4f60\u4eec\u7684CAPA\u662f\u5426\u8db3\u4ee5\u5904\u7406\u4f60\u4eec\u7684\u5b9e\u9a8c\u5ba4\u83b7\u5f97\u7684OOS (b)(4) \u7ed3\u679c\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">It lacked sufficient details on the evaluation of additional (b)(4) products produced with the same manufacturing equipment used for the (b)(4) injection (b)(4) and (b)(4).&nbsp;<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5176\u4e2d\u5bf9\u5728XX\u6ce8\u5c04\u5242\u548cXX\u6240\u7528\u76f8\u540c\u751f\u4ea7\u8bbe\u5907\u4e2d\u751f\u4ea7\u7684\u5176\u5b83XX\u4ea7\u54c1\u7684\u8bc4\u4f30\u4e0d\u591f\u8be6\u7ec6<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">In your response to this letter, provide:<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u56de\u590d\u6b64\u51fd\uff0c\u8bf7\u63d0\u4ea4\uff1a<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">Your final report on the improvements needed to ensure that (b)(4) processes will reproducibly meet required quality attributes.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4f60\u4eec\u786e\u4fddXX\u5de5\u827a\u80fd\u91cd\u590d\u7b26\u5408\u6240\u9700\u8d28\u91cf\u5c5e\u6027\u6240\u9700\u7684\u6539\u8fdb\u7684\u6700\u7ec8\u62a5\u544a<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">An evaluation of the design and state of control of each (b)(4) cycle used to produce drug products for U.S. supply. Include a retrospective assessment of all investigations (e.g., process deviations, failures, complaints) related to (b)(4) drug products not recalled from the U.S. market. Summarize the root causes assigned for identified defects, the adequacy of the CAPA, and any further steps needed.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7528\u4e8e\u751f\u4ea7\u7f8e\u56fd\u5e02\u573a\u836f\u54c1\u7684\u6bcf\u4e2aXX\u5468\u671f\u7684\u8bbe\u8ba1\u548c\u53d7\u63a7\u72b6\u6001\u7684\u8bc4\u4f30\uff0c\u5305\u62ec\u5bf9\u6240\u6709\u4e0e\u672a\u4ece\u7f8e\u56fd\u5e02\u573a\u53ec\u56de\u7684XX\u836f\u54c1\u6709\u5173\u7684\u8c03\u67e5\u7684\u56de\u987e\u6027\u8bc4\u4f30\uff08\u4f8b\u5982\u5de5\u827a\u504f\u5dee\u3001\u4e0d\u5408\u683c\u3001\u6295\u8bc9\uff09\u3002\u603b\u7ed3\u6240\u53d1\u73b0\u7f3a\u9677\u5f52\u7ed3\u7684\u6839\u672c\u539f\u56e0\uff0cCAPA\u7684\u5145\u5206\u6027\u548c\u6240\u9700\u7684\u66f4\u591a\u6b65\u9aa4\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">Your CAPA for routine, vigilant operations management oversight of facilities and equipment to assure prompt detection of equipment performance issues, execution of repairs, completion of preventive maintenance, upgrades to equipment and facilities, and other appropriate actions.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4f60\u4eec\u76d1\u7ba1\u8bbe\u65bd\u548c\u8bbe\u5907\u7528\u4ee5\u786e\u4fdd\u53ca\u65f6\u53d1\u73b0\u8bbe\u5907\u6027\u80fd\u95ee\u9898\u3001\u6267\u884c\u4fee\u7406\u3001\u5b8c\u6210\u9884\u9632\u6027\u7ef4\u62a4\u3001\u8bbe\u5907\u548c\u8bbe\u65bd\u5347\u7ea7\u4ee5\u53ca\u5176\u5b83\u9002\u5f53\u63aa\u65bd\u7684\u5e38\u89c4\u3001\u8b66\u6212\u64cd\u4f5c\u7ba1\u7406CAPA<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">3. &nbsp; &nbsp;Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).<\/span><\/strong><\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 14px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4f60\u4eec\u516c\u53f8\u672a\u5728\u653e\u884c\u524d\u5bf9\u6bcf\u6279\u836f\u54c1\u8fdb\u884c\u9002\u5f53\u7684\u5b9e\u9a8c\u5ba4\u68c0\u6d4b\uff0c\u786e\u5b9a\u5176\u7b26\u5408\u836f\u54c1\u7684\u6700\u7ec8\u8d28\u91cf\u6807\u51c6\uff0c\u5305\u62ec\u6bcf\u79cd\u6d3b\u6027\u6210\u5206\u7684\u9274\u522b\u548c\u5242\u91cf\uff0821 CFR 211.165(a)\uff09\u3002&nbsp;<\/span><\/strong><\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">From February 16 to March 20, 2018, you tested (b)(4) batches of (b)(4) API for (b)(4). All results were reported as passing. However, during the FDA inspection on March 28, 2018, we requested retesting the same batches under our observation. All retest results were OOS.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4ece20180206\u81f302180320\uff0c\u4f60\u4eec\u68c0\u9a8c\u4e86XX\u6279\u6b21XX\u7528XX\u539f\u6599\u836f\u3002\u6240\u6709\u7ed3\u679c\u5747\u62a5\u544a\u4e3a\u5408\u683c\u3002\u4f46\u662f20180328\u5728FDA\u68c0\u67e5\u671f\u95f4\uff0c\u6211\u4eec\u8981\u6c42\u5728\u6211\u4eec\u89c2\u5bdf\u4e0b\u590d\u6d4b\u76f8\u540c\u7684\u6279\u6b21\uff0c\u6240\u6709\u7ed3\u679c\u5747\u4e3aOOS\u3002<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">A batch of (b)(4) finished product, initially tested on May 25, 2017, was also retested on March 28, 2018, and found to be OOS.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e00\u6279XX\u6210\u54c1\uff0c\u521d\u6d4b\u65f6\u95f4\u4e3a20170525\uff0c\u4ea6\u572820180328\u8fdb\u884c\u4e86\u590d\u6d4b\uff0c\u7ed3\u679c\u4e3aOOS\u3002<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">Further, on April 2, 2018, your management informed our investigator that the (b)(4) test for (b)(4) batch (b)(4) raw material was repeated and that all (b)(4) replicates failed to meet the specification.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">20180402\uff0c\u4f60\u4eec\u9ad8\u7ea7\u7ba1\u7406\u5c42\u901a\u77e5\u6211\u4eec\u8c03\u67e5\u4eba\u5458\u8bf4XX\u6279\u6b21XX\u539f\u6599\u7684XX\u68c0\u6d4b\u6b63\u5728\u91cd\u590d\uff0c\u6240\u6709XX\u5e73\u884c\u7ed3\u679c\u5747\u4e0d\u7b26\u5408\u8d28\u91cf\u6807\u51c6\u3002<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">Our investigators noted that your analysts did not have a timer to indicate the start and end of (b)(4) reported in your laboratory record of analysis. It was unclear if analysts were (b)(4) the (b)(4) samples for the full (b)(4) required.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6211\u4eec\u7684\u68c0\u67e5\u5458\u6ce8\u610f\u5230\u4f60\u4eec\u7684\u5316\u9a8c\u5458\u5e76\u6ca1\u6709\u8ba1\u65f6\u5668\u6765\u6307\u793a\u4f60\u4eec\u5b9e\u9a8c\u5ba4\u5206\u6790\u8bb0\u5f55\u4e2d\u6240\u62a5\u544a\u7684XX\u5f00\u59cb\u548c\u7ed3\u675f\u65f6\u95f4\u3002\u4e0d\u592a\u6e05\u695a\u5316\u9a8c\u5458\u662f\u5426XX\u6837\u54c1\u7528\u4e8e\u6240\u9700\u7684\u5168\u90e8XX\u3002&nbsp;<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">In your response, you indicated that your investigation had revealed data integrity issues related to reporting (b)(4) test results. You also indicated that your investigation, still in progress, has identified laboratory equipment failure as a probable root cause for the failing (b)(4) results. More specifically, inefficient removal of (b)(4) from the (b)(4) is considered to be the cause of incomplete (b)(4) of the sample.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5728\u4f60\u4eec\u7684\u56de\u590d\u4e2d\uff0c\u4f60\u4eec\u8bf4\u4f60\u4eec\u7684\u8c03\u67e5\u663e\u793aXX\u68c0\u9a8c\u7ed3\u679c\u62a5\u544a\u6709\u6570\u636e\u5b8c\u6574\u6027\u95ee\u9898\u3002\u4f60\u4eec\u8fd8\u8bf4\u4f60\u4eec\u8c03\u67e5\u4ecd\u5728\u8fdb\u884c\u4e2d\uff0c\u5c06\u5b9e\u9a8c\u5ba4\u8bbe\u5907\u5931\u8d25\u4f5c\u4e3a\u4e0d\u5408\u683cXX\u7ed3\u679c\u53ef\u80fd\u7684\u6839\u672c\u539f\u56e0\u3002\u66f4\u4e3a\u5177\u4f53\u5730\u8bf4\uff0c\u672a\u80fd\u6709\u6548\u4eceXX\u4e2d\u6e05\u9664XX\u88ab\u8ba4\u4e3a\u662f\u6837\u54c1\u4e0d\u5b8c\u5168XX\u7684\u539f\u56e0\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">We acknowledge your decision to suspend all (b)(4) testing. However, you did not include an assessment to determine whether other QC laboratory tests performed in the same laboratory were compromised by data integrity issues. Your response also fails to discuss the extent of data integrity breaches in your facility.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6211\u4eec\u77e5\u6089\u4f60\u4eec\u51b3\u5b9a\u6682\u505c\u6240\u6709\u7684XX\u68c0\u6d4b\u3002\u4f46\u662f\uff0c\u4f60\u4eec\u5e76\u672a\u786e\u5b9a\u5728\u76f8\u540c\u5b9e\u9a8c\u5ba4\u8fdb\u884c\u7684\u5176\u5b83QC\u5b9e\u9a8c\u5ba4\u68c0\u6d4b\u662f\u5426\u53d7\u6570\u636e\u5b8c\u6574\u6027\u95ee\u9898\u5f71\u54cd\u3002\u4f60\u4eec\u7684\u56de\u590d\u4ea6\u672a\u8ba8\u8bba\u4f60\u4eec\u5de5\u5382\u5185\u6570\u636e\u5b8c\u6574\u6027\u95ee\u9898\u7684\u7a0b\u5ea6\u3002<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;&nbsp;<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">In a Field Alert Report (FAR) of July 20, 2018, regarding OOS (b)(4) results, you indicated that \u201canalysts performing the (b)(4) test did not perform the analysis in accordance with procedures and did not record the data accurately in the past.\u201d Also, \u201cthere may be instances where testing results for the Karl Fisher test, gas chromatography, infrared spectroscopy and ultraviolet spectroscopy were not recorded accurately.\u201d<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u572820180720\u7684FAR\u4e2d\uff0c\u5173\u4e8eOOS XX\u7ed3\u679c\uff0c\u4f60\u4eec\u8bf4\u201c\u8fc7\u53bb\u6267\u884cXX\u68c0\u6d4b\u7684\u5316\u9a8c\u5458\u5e76\u672a\u6839\u636e\u7a0b\u5e8f\u8fdb\u884c\u68c0\u9a8c\uff0c\u4e14\u672a\u51c6\u786e\u8bb0\u5f55\u6570\u636e\u201d\u3002\u8fd8\u6709\uff0c\u201c\u53ef\u80fd\u6709\u65f6KF\u6c34\u5206\u68c0\u6d4b\u3001\u6c14\u76f8\u3001\u7ea2\u5916\u5149\u8c31\u548c\u7d2b\u5916\u5149\u8c31\u5747\u6709\u8bb0\u5f55\u4e0d\u51c6\u786e\u7684\u60c5\u51b5\u201d\u3002<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">In your response to this letter, include:<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u56de\u590d\u6b64\u51fd\uff0c\u8bf7\u5305\u62ec\uff1a<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">A comprehensive CAPA to ensure all batches of (b)(4) finished product intended for the U.S. market meet all established specifications. Include your results from testing reserve samples of all drugs (active ingredient and finished drug product) that remain within retest period or expiry in the U.S. market.<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e00\u4efd\u5168\u9762CAPA\uff0c\u786e\u4fdd\u6240\u6709\u51c6\u5907\u9500\u5f80\u7f8e\u56fd\u7684XX\u6210\u54c1\u6279\u51c6\u7b26\u5408\u65e2\u5b9a\u8d28\u91cf\u6807\u51c6\u3002\u5305\u62ec\u4f60\u4eec\u5bf9\u6240\u6709\u9500\u552e\u5f80\u7f8e\u56fd\u4ecd\u5728\u6548\u671f\u5185\u6216\u590d\u9a8c\u671f\u5185\u836f\u54c1\uff08\u6d3b\u6027\u6210\u5206\u548c\u5236\u5242\u6210\u54c1\uff09\u7559\u6837\u7684\u68c0\u6d4b\u7ed3\u679c\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\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: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">Your market action plan for all batches with reserve sample testing found to be OOS or inaccurately reported (e.g., as identified by your independent third party).<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(0, 128, 255);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4f60\u4eec\u5bf9\u7559\u6837\u68c0\u9a8c\u4e3aOOS\u6216\u4e0d\u51c6\u786e\u62a5\u544a\uff08\u4f8b\u5982\uff0c\u4f60\u4eec\u72ec\u7acb\u7b2c\u4e09\u65b9\u6240\u53d1\u73b0\u7684\uff09\u7684\u6240\u6709\u6279\u6b21\u7684\u5e02\u573a\u884c\u52a8\u8ba1\u5212<\/span><\/p>\n<section><mpcps frameborder=\"0\" class=\"js_editor_cps\"  style=\"width:100% !important;border:0;\"           ><\/mpcps><\/section>\n<p><br  \/><\/p>\n<\/section>\n<\/section>\n<p><br  \/><\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>FDA\u4e8e2018.03.27-04.03\uff0c\u7531\u68c0\u5bdf\u5b98Jose E Melendez\u548cAdemola O Dara [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":81662,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/81661"}],"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=81661"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/81661\/revisions"}],"predecessor-version":[{"id":81665,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/81661\/revisions\/81665"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/81662"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=81661"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=81661"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=81661"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}