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本帖最后由 kslam 于 2016-10-12 08:00 编辑
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd., at No. 1 Sitong Road, Hanji Industrial Park, Yangzhou, Jiangsu, from January 18 to 22, 2016.
FDA从2016年1月18日至22日检查您的制药造设, 施扬州恒源日化塑料有限公司在江苏扬州市杭集镇工业园。
This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.
此警告函总结了药品CGMP 210和211严重违规。
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), 21 U.S.C. 351(a)(2)(B).
We reviewed your firm’s January 30, 2016, response in detail.
我们仔细审核了贵公司2016年1月30日的回复。
During our inspection, our investigator observed specific violations including, but not limited to, the following.
检查期间,我们的调查员发现的具体问题包括但不仅限于:
1. Your firm failed to provide adequate written production and control procedures which are designed to assure that the drug products produced have the identity, strength, quality and purity they purport or are represented to possess (21 CFR 211.101).
贵公司未能提供足够的生产和控制书面程序,其目的是确保生产的药品具有的属性,含量,质量和纯度(21 CFR 211.101)。
2. Your firm does not 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)).
贵公司没有每批药品放行前经适当实验室检测,满足符合最终质量标准包括每种活性成份的属性准和含量。
FDA placed your firm on Import Alert 66-40 on August 12, 2016.
FDA于2016年8月12日将您的公司置于进口警示66-40。
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