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...
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 ...
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...
FDA检查员就483表格内容与药品生产企业管理层进行讨论,确保其充分理解检查缺陷,并在检查结束时将483表格发送给管理层。483表格代表FDA对是否违反FD & C法案或相关法规的最终决定,FDA会就483表格、检查报告、现场收集的所有证据或文件、企业回复整...
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.
In response to this letter, provide: 在检查后的后续沟通中,你们披露你们的工厂和全球质量组织都在2024年1月意识到与组件测试相关的数据完整性问题。FDA担心你们在有FDA检查之后才充分调查或开始实施整体纠正措施。 2. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch...
我们详细审查了贵公司2024 年 7 月 18 日对我们的 FDA 483 表的答复,并确认收到了贵公司随后的信函。 During our inspection, our investigators observed specific violations including, but not limited to, the following. 在检...
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....
It adds tips which cGMP can use to respond in Form 438 Letters such as responding within 15 days to assure the final proofing and editing and individually answering the addressed concerns written in the warning letter.AppelKenEBSCO_bspManufacturing Chemist...