正文
以及
21U.S.C. 351(a)(2)(B)
被认为是掺假药品。
We reviewed your July 6, 2017,response in detail. You did not commit to any corrective actions regarding theCGMP violations observed during the inspection and stated that you “will not beable for the time being to comply with USA Good Manufacturing Practices for OTCpharmaceuticals,” and “will therefore immediately cease to sell and ship toUSA.”
我们已详细审核了你公司
2017
年
7
月
6
日的回复。你们未承诺针对检查期间发现的
CGMP
违规情况采取任何纠正措施，并且声明你们
“
目前没有能力符合
USA
的
OTC
药品
GMP”
，并且
“
不会立即停止向
USA
销售和发货。
”
During our inspection, ourinvestigator observed specific violations including, but not limited to, thefollowing.
检查期间，我们的调查人员发现的具体问题包括但不仅限于以下：
1. Your firm failed to have,for each batch of drug product, appropriate laboratory determination ofsatisfactory 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)).
你们公司未对每批药品进行适当的化验室测试，确保其在放行之前符合药品的最终标准，包括每种活性成分的鉴别和剂量
(21CFR 211.165(a))
。
Your firm failed to testyour drug products for identity and strength of active ingredients priorto release and distribution.
你公司在药品放行和销售之前未能测试你们药品中活性成分的鉴别和含量。
2. Your firm failed to ensurethe identity of components sourced from various suppliers, including youractive ingredients (21 CFR 211.84(d)(1) and (2)).
你们公司未能确保来自不同供应商的各成分的鉴别，包括你们的活性成分
