{"id":47310,"date":"2018-09-18T01:00:00","date_gmt":"2018-09-26T01:38:51","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/26\/fda%e8%ad%a6%e5%91%8a%e4%bf%a1%ef%bc%9a%e8%93%9d%e6%88%88%e5%8c%bb%e8%8d%af%e7%94%a8%e5%93%81%ef%bc%88%e5%8c%97%e4%ba%ac%ef%bc%89\/"},"modified":"2018-09-26T09:38:51","modified_gmt":"2018-09-26T01:38:51","slug":"fda%e8%ad%a6%e5%91%8a%e4%bf%a1%ef%bc%9a%e8%93%9d%e6%88%88%e5%8c%bb%e8%8d%af%e7%94%a8%e5%93%81%ef%bc%88%e5%8c%97%e4%ba%ac%ef%bc%89","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/47310\/","title":{"rendered":"FDA\u8b66\u544a\u4fe1\uff1a\u84dd\u6208\u533b\u836f\u7528\u54c1\uff08\u5317\u4eac\uff09"},"content":{"rendered":"
\n

 \u7ffb\u8bd1\uff1aJULIA  \u6765\u6e90\uff1a<\/span>Julia\u6cd5\u89c4\u7ffb\u8bd1<\/span> <\/span><\/p>\n


<\/span><\/strong><\/p>\n

Warning Letter 320-18-72<\/span><\/strong>                    <\/span><\/strong>August 27, 2018<\/span><\/span><\/p>\n

Mr. Shenglin Gao<\/span><\/p>\n

General Manager, Longood Medicine (Beijing) Co., Ltd.<\/span><\/p>\n

No. 13, Yunteng Road, Miyun Economic Development Area, Beijing 101500,China              <\/span><\/p>\n

 <\/span><\/p>\n

Dear Mr. Gao:<\/span><\/p>\n

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Longood Medicine (Beijing) Co., Ltd. at No. 13, Yunteng Road, Beijing, from September 25 to 29, 2017.<\/span><\/p>\n

\u7f8e\u56fd<\/span>FDA<\/span>\u4e8e<\/span>2017<\/span>\u5e74<\/span>9<\/span>\u6708<\/span>25-29<\/span>\u65e5\u68c0\u67e5\u4e86\u4f60\u4eec\u4f4d\u4e8e\u4e2d\u56fd\u5317\u4eac\u5e02\u5bc6\u4e91\u53bf\u7ecf\u6d4e\u6280\u672f\u5f00\u53d1\u533a\u4e91\u817e\u8def<\/span>13<\/span>\u53f7\u7684\u84dd\u6208\u533b\u836f\u7528\u54c1\uff08\u5317\u4eac\uff09\u6709\u9650\u516c\u53f8\u751f\u4ea7\u573a\u6240\u3002<\/span><\/span><\/p>\n


<\/span><\/span><\/p>\n

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

\u672c\u8b66\u544a\u4fe1\u603b\u7ed3\u4e86\u5236\u5242\u751f\u4ea7\u4e25\u91cd\u8fdd\u53cd<\/span>CGMP<\/span>\u7684\u884c\u4e3a\u3002\u53c2\u89c1<\/span>21CFR<\/span>\u7b2c<\/span>210<\/span>\u548c<\/span>211<\/span>\u90e8\u5206<\/span>.<\/span><\/span><\/p>\n

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&C Act), 21U.S.C. 351(a)(2)(B).<\/span><\/p>\n

\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\u5408<\/span>CGMP<\/span>\u8981\u6c42\uff0c\u4f60\u4eec\u7684\u5236\u5242\u6839\u636e<\/span>FDCA<\/span>\u7684<\/span>501(a)(2)(B)<\/span>\u4ee5\u53ca<\/span>21U.S.C. 351(a)(2)(B)<\/span>\u88ab\u8ba4\u4e3a\u662f\u63ba\u5047\u836f\u54c1\u3002<\/span><\/span><\/p>\n


<\/span><\/span><\/p>\n

Your firm also manufactures unapproved new drug products in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a).<\/span><\/p>\n

\u4f60\u516c\u53f8\u4ea6\u751f\u4ea7\u4e86\u672a\u7ecf\u6279\u51c6\u7684\u65b0\u836f\uff0c\u8fdd\u53cd\u4e86<\/span>FDAC<\/span>\u7b2c<\/span>505(a)<\/span>\u90e8\u5206<\/span>21 U.S.C. 355(a)<\/span>\u3002<\/span><\/span><\/p>\n


<\/p>\n

We reviewed your October 13, 2017,r esponse in detail and acknowledge receipt of subsequent correspondence.<\/span><\/p>\n

 <\/span>\u6211\u4eec\u8be6\u7ec6\u5ba1\u6838\u4e86\u4f60\u4eec\u4e8e<\/span>2017<\/span>\u5e74<\/span>10<\/span>\u6708<\/span>13<\/span>\u65e5\u53d1\u6765\u7684\u56de\u590d\u5e76\u4e14\u544a\u77e5\u5df2\u6536\u6089\u540e\u7eed\u901a\u4fe1\u3002<\/span><\/span><\/p>\n


<\/span><\/span><\/p>\n

During our inspection, our investigator observed specific violations including, but not limited to, the following.<\/span><\/p>\n

\u68c0\u67e5\u671f\u95f4\uff0c\u6211\u4eec\u7684\u8c03\u67e5\u4eba\u5458\u53d1\u73b0\u7684\u5177\u4f53\u95ee\u9898\u5305\u62ec\u4f46\u4e0d\u4ec5\u9650\u4e8e\u4ee5\u4e0b\uff1a<\/span><\/p>\n


<\/span><\/p>\n

CGMP Violations<\/span><\/strong> CGMP<\/span><\/span><\/strong>\u8fdd\u89c4<\/span><\/strong><\/span><\/p>\n

1.   Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products, including drug products manufactured, processed, packed or heldunder contract by another company. Your firm failed to establish a quality unit with the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated (21 CFR 211.22(a)). <\/span><\/strong> <\/span><\/strong><\/span><\/p>\n

\u4f60\u516c\u53f8\u672a\u80fd\u5efa\u7acb\u8db3\u591f\u7684\u8d28\u91cf\u90e8\u95e8\uff0c\u4f7f\u5176\u5177\u5907\u6279\u51c6\u6216\u62d2\u6536\u6240\u6709\u7ec4\u4efd\u3001\u5236\u5242\u5bb9\u5668\u5bc6\u95ed\u5668\u3001\u4e2d\u95f4\u4f53\u3001\u5305\u6750\u3001\u6807\u7b7e\u548c\u5236\u5242\u6210\u54c1\uff0c\u5305\u62ec\u59d4\u6258\u7ed9\u53e6\u4e00\u516c\u53f8\u751f\u4ea7\u3001\u52a0\u5de5\u3001\u5305\u88c5\u6216\u4fdd\u5b58\u7684\u836f\u54c1\u7684\u804c\u8d23\u548c\u6743\u529b\u3002\u4f60\u516c\u53f8\u672a\u80fd\u5efa\u7acb\u8d28\u91cf\u90e8\u95e8\uff0c\u4f7f\u5176\u5177\u5907\u6743\u529b\u5ba1\u6838\u751f\u4ea7\u8bb0\u5f55\u4ee5\u786e\u4fdd\u4e0d\u4f1a\u6709\u9519\u8bef\u53d1\u751f\uff0c\u6216\u8005\u5728\u53d1\u751f\u9519\u8bef\u65f6\u4f1a\u7ecf\u4f1a\u5168\u9762\u8c03\u67e5\uff08<\/span><\/strong>21 CFR 211.22(a)<\/span><\/strong>\uff09\u3002<\/span><\/strong><\/span><\/p>\n


<\/span><\/strong><\/span><\/p>\n

Contractor Oversight<\/span><\/em> \u5408\u540c\u751f\u4ea7\u5546\u76d1\u7ba1<\/span><\/em><\/span><\/p>\n

You failed to ensure that your third-party contractor uses a validated terminal sterilization process, consistent with the requirements of 21 CFR 211.113(b), to sterilize your drug product, Chlora-Cleanze Proprep applicators, purported as sterile and labeled for \u201cuse prior to surgery.\u201d   <\/span><\/p>\n

\u4f60\u672a\u80fd\u786e\u4fdd\u4f60\u4eec\u7684\u7b2c\u4e09\u65b9\u751f\u4ea7\u5546\u4f7f\u7528\u7ecf\u8fc7\u9a8c\u8bc1\u7684\u7ec8\u7aef\u706d\u83cc\u5de5\u827a\u5bf9\u4f60\u4eec\u4ea7\u54c1<\/span>Chlora-Cleanze Proprep<\/span>\u6d82\u88c5\u5668\u8fdb\u884c\u706d\u83cc\uff0c\u4f7f\u5176\u7b26\u5408<\/span>21 CFR 211.113(b)<\/span>\u8981\u6c42\u3002\u8be5\u4ea7\u54c1\u7406\u5e94\u4e3a\u65e0\u83cc\uff0c\u5e76\u6807\u793a\u4e3a\u201c\u5916\u79d1\u624b\u672f\u524d\u4f7f\u7528\u201d\u3002<\/span><\/span><\/p>\n


<\/span><\/span><\/p>\n

You released Chlora-Cleanze Proprep applicators without assurance of their sterility. For example, you were unable to provide adequate records demonstrating that your contractor terminally sterilized Chlora-Cleanze Proprep applicators lot 20170601, distributed to the United States. You also failed to provide evidence that your quality unit reviewed all appropriate records prior to releasing the lot.  <\/span><\/p>\n

 <\/span>\u4f60\u4eec\u653e\u884c\u4e86<\/span>Chlora-Cleanze Proprep<\/span>\u6d82\u88c5\u5668\u5374\u672a\u786e\u4fdd\u5176\u65e0\u83cc\u6027\u3002\u4f8b\u5982\uff0c\u4f60\u4eec\u672a\u80fd\u63d0\u4ea4\u8db3\u591f\u7684\u8bb0\u5f55\u8bc1\u660e\u4f60\u4eec\u5408\u540c\u751f\u4ea7\u5546\u5bf9\u9500\u5f80\u7f8e\u56fd\u7684<\/span>Chlora-Cleanze Proprep<\/span>\u6d82\u88c5\u5668\u6279\u53f7<\/span>20170601<\/span>\u8fdb\u884c\u4e86\u6700\u7ec8\u706d\u83cc\u3002\u4f60\u4eec\u4ea6\u672a\u63d0\u4ea4\u8bc1\u636e\u8bc1\u660e\u4f60\u4eec\u8d28\u91cf\u90e8\u95e8\u5728\u653e\u884c\u8be5\u6279\u6b21\u4e4b\u524d\u5ba1\u6838\u4e86\u6240\u6709\u9002\u5f53\u7684\u8bb0\u5f55\u3002<\/span><\/span><\/p>\n


<\/span><\/span><\/p>\n

In your response, you acknowledged that your terminal sterilization contractor provided incomplete records for Chlora-Cleanze Proprep applicators (lot 20170601). Your response is inadequate.You failed to describe how your firm determined the lot was acceptable for release without complete documentation from your contractor. In addition, you failed to provide evidence from your contractor demonstrating this lot was terminally sterilized.    <\/span><\/p>\n

\u5728\u4f60\u4eec\u7684\u56de\u590d\u4e2d\uff0c\u4f60\u4eec\u8bf4\u4f60\u4eec\u7684\u6700\u7ec8\u706d\u83cc\u5408\u540c\u751f\u4ea7\u5546\u63d0\u4f9b\u4e86<\/span>Chlora-Cleanze Proprep<\/span>\u6d82\u88c5\u5668\uff08\u6279\u53f7<\/span>20170601<\/span>\uff09\u4e0d\u5b8c\u6574\u8bb0\u5f55\u3002\u4f60\u4eec\u7684\u56de\u590d\u662f\u4e0d\u5145\u5206\u7684\u3002\u4f60\u4eec\u672a\u80fd\u8bf4\u660e\u4f60\u4eec\u516c\u53f8\u662f\u5982\u4f55\u786e\u5b9a\u5728\u6ca1\u62ff\u5230\u5408\u540c\u5546\u5b8c\u6574\u8bb0\u5f55\u65f6\u8be5\u6279\u6b21\u53ef\u4ee5\u653e\u884c\u7684\u3002\u6b64\u5916\uff0c\u4f60\u4eec\u672a\u80fd\u63d0\u4f9b\u4ece\u4f60\u4eec\u5408\u540c\u5546\u5904\u83b7\u5f97\u7684\u8bc1\u636e\u6765\u8bc1\u660e\u8be5\u6279\u51c6\u7ecf\u8fc7\u4e86\u7ec8\u7aef\u706d\u83cc\u3002<\/span><\/span><\/p>\n


<\/span><\/span><\/p>\n

Your response also provided terminal sterilization validation documentation for a different (b)(4)<\/strong> product ((b)(4)<\/strong>) to support the sterilization of Chlora-Cleanze Proprep applicators. Your response is inadequate in that it lacks sufficient validation data to support sterilization efficacy. You did not provide scientific rationale demonstrating validation studies for the (b)(4)<\/strong> sterilization process are representative of the sterilization process for Chlora-Cleanze Proprep applicators. (b)(4)<\/strong> drug product has a different formulation, includinga different active ingredient. You failed to address whether you will validatethe terminal sterilization process for the Chlora-Cleanze Proprep applicators.<\/span><\/p>\n

\u4f60\u4eec\u7684\u56de\u590d\u8fd8\u63d0\u4ea4\u4e86\u4e0d\u540c<\/span>XX<\/span>\u4ea7\u54c1<\/span>XX<\/span>\u7684\u6700\u7ec8\u706d\u83cc\u9a8c\u8bc1\u6587\u4ef6\u7528\u4ee5\u652f\u6301<\/span>Chlora-Cleanze Proprep<\/span>\u6d82\u88c5\u5668\u7684\u706d\u83cc\u3002\u4f60\u4eec\u7684\u56de\u590d\u662f\u4e0d\u5145\u5206\u7684\uff0c\u5b83\u7f3a\u4e4f\u8db3\u591f\u7684\u9a8c\u8bc1\u6570\u636e\u652f\u6301\u706d\u83cc\u6709\u6548\u6027\u3002\u4f60\u4eec\u672a\u63d0\u4ea4\u79d1\u5b66\u5408\u7406\u8bba\u8bc1\u8bc1\u660e<\/span>XX<\/span>\u706d\u83cc\u5de5\u827a\u7684\u9a8c\u8bc1\u7814\u7a76\u53ef\u4ee3\u8868<\/span>Chlora-Cleanze Proprep<\/span>\u6d82\u88c5\u5668\u7684\u706d\u83cc\u5de5\u827a\u3002<\/span>XX<\/span>\u836f\u54c1\u6709\u7740\u4e0d\u540c\u7684\u914d\u65b9\uff0c\u5305\u62ec\u4e0d\u540c\u7684\u6d3b\u6027\u6210\u5206\u3002\u4f60\u4eec\u672a\u80fd\u8bf4\u660e\u4f60\u4eec\u662f\u5426\u8981\u9a8c\u8bc1<\/span>Chlora-Cleanze Proprep<\/span>\u6d82\u88c5\u5668\u7684\u7ec8\u7aef\u706d\u83cc\u5de5\u827a\u3002<\/span><\/span><\/p>\n


<\/span><\/span><\/p>\n

In your response to this letter, provide:<\/span>\u5728\u56de\u590d\u6b64\u51fd\u65f6\u8bf7\u63d0\u4ea4\uff1a<\/span><\/span><\/p>\n