FDA also cited a similar CGMP violation at other facilities in your company’s network. Sun Pharmaceutical Industries Ltd., (Halol site), FEI 3002809586, was issued a warning letter dated December 15, 2022 (later amended and dated October 16, 2023), for violation of, among other items, 21 ...
First and foremost, it’s important to take these observations seriously. Although it does not represent the FDA’s final determination on compliance, deciding not to respond to FDA 483 observations within the 15-business day window will almost certainly...
Need to find a particular FDA Form 483, 483R, or EIR? Search one of the world’s largest databases of those documents outside of the FDA itself. Easily add to cart and checkout.
FDA 483避免与应对指南：温度、湿度和其他受控环境说明书 How to Avoid (and Respond to) FDA 483s for Temperature, Humidity and other Controlled Environments No cGMP compliant manufacturer wants to receive a Form 483 (“Notice of Inspectional Observations”). In such stringently controlled industries as...
[13]FDA. Warning Letter Actavis Laboratories FL,Inc.[EB / OL].(2019 - 03 - 05)[2024 - 04 - 03]. https:// www. fda. gov /inspections - compliance - enforcement - and - criminal - in⁃vestigations / warning - ...
FDA 483: 徜徉于一垃圾车撕碎文件中的FDA检查官(FDA 483: 徜徉于一垃圾车撕碎文件中的FDA检查官) Intas的这个 一卡车碎片文件,年初看到确实很震撼。下面不多说,正文部分对于如何整改写的很细。 Warning Letter 320-23-20 警告信 320-23-20 July 28, 2023 7月 28, 2023 Dear Mr. Chudgar: 亲爱的...
[12]FDA. Warning Letter Intas Pharmaceuticals Limited[EB / OL].(2023 - 11 - 28)[2024 - 04 - 03]. https:// www. fda. gov /inspections - compliance - enforcement - and - criminal - in⁃vestigations / warning - letters / intas - pharmaceuticals - lim⁃ited - 662868 - 11212023....
另外,根据FDA官网统计,2016年FDA医疗器械工厂审核(依据法规CFR21 QSR820)Warning letter缺陷项中,排名前十的QSR820条款如下表所示: 根据上表所示:排名前三的严重缺陷项条款都是 CAPA下的条款,分别是:21CFR 820.100(a)、21CFR 820.198(a)、21CFR 820.90(a)。生产与过程控制子系统下的条款则分别排名在第5、7、9,...
另外,根据FDA官网统计,2016年FDA医疗器械工厂审核(依据法规CFR21 QSR820)Warning letter缺陷项中,排名前十的QSR820条款如下表所示: 根据上表所示:排名前三的严重缺陷项条款都是 CAPA下的条款,分别是:21CFR 820.100(a)、21CFR 820.198(a)、21CFR 820.90(a)。生产与过程控制子系统下的条款则分别排名在第5、7、9,...
这个链接就是fda的warning letter database链接，点进去之后根据你要查的公司的方向进入相关的database查询...