FDA给印度生产商Polydrug的警告信(内容很不可思议)

FDA给印度生产商Polydrug的警告信(内容很不可思议)

April 14, 2016 Mr. Punit Thakrar, Managing DirectorPolydrug Laboratories Pvt. Ltd. Corporate OfficeA

201-202, Navbharat Estates, Zakaria Bonder RoadSewri

(W)Mumbai – 400015Maharashtra, India Dear Mr. Thakrar: From March 16-23, 2015, an investigator from the U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Polydrug Laboratories Pvt. Ltd., Plot

N-37, Addl. Ambarnath Industrial Area, MIDC, Anand Nagar, Ambarnath (East), Maharashtra, Mumbai.2015年3月16-23日，我们FDA的调查员检查了你们位于上述地址的生产工厂。We identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients (API).我们发现了严重违反原料药生产CGMP的问题。

These deviations cause your drugs to be 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), in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.

这些问题导致你们生产的药品根据联邦食品药品化妆品法

案501(a)(2)(B) 部分21 U.S.C. 351(a)(2)(B)被认定为掺假药。We have reviewed your April 9, 2015, response in detail and acknowledge receipt of your subsequent response.我们已经详

细审核了你们于2015年4月9日的回复，并且告知已收到之后的回复。

Our investigator observed specific deviations during the inspection, including, but not limited to, the following.我们的调查员在检查期间发现的具体违规情况，包括但不限于以下：1. Failure to record and investigate all quality-related customer complaints according to an established procedure.未能根据既

定程序记录和调查所有与质量相关的客户投诉。

During the inspection our investigator found a torn sheet of paper titled “Product Quality Complaints” on the floor of your warehouse. We compared it to your firm’s official complaint log and discovered that only 2 of the 17 customer complaints on the torn sheet were recorded in your firm’s official complaint log. Further, your firm indicated that there may be additional unlogged and/or uninvestigated complaints, but did not provide further explanation. Your firm had not investigated the complaints we found on the torn sheet. These uninvestigated complaints reported API that were either sub-potent or contained

filth, including the following problems:在检查期间，我们的调查员在你们仓库的地面上发现了一张被撕毁的表，标题是“产品质量投诉”。我们将它与你们公司的正式投诉登记本进行了比较，发现在被撕毁的表上有17个投诉，而在公司正式的客诉登记本上只登记了2条。还有，你们公司说可能还有其它没有登记和/或没有调查的投诉，但没有做出进一步解释。你们公司没有对我们在被撕毁的表上发现的那些投诉。这些未经调查的投诉报告了原料药效价不达标以及受到污染的情况。

low assay value for (b)(4) API某原料药含量低particles and hairs in (b)(4) API某原料药发现颗粒和头发an insect and dirt in (b)(4) API原料药里发现昆虫和脏物safety goggles in (b)(4) API原料药里发现护目镜(b)(4) scoop in (b)(4) API 原料药里发现料勺

Your response stated that you will initiate a corrective action and preventive action (CAPA) plan to include your quality unit’s assessment of your current practices.你们的回复说你们会启动CAPA计划，其中会包括你们质量部门对现行做法的评估。Your response is inadequate because it is silent on any retrospective investigations conducted for the 17 complaints that our investigator found on the sheet of paper on your warehouse floor. Your response also did not specify improvements to your