FDA对汕尾*日用品公司的警告信

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ECA新闻：不符合质量标准引发的警告信Julia法规翻译
Warning Letter due toNon-Compliance with Specifications不符合质量标准引发的警告信

This FDA Warning Letter issued to Chinese pharmaceuticalmanufacturer Shanwei Honghui Daily Appliance Co. Ltd. in China from 05December, 2017, is based on an FDA inspection from July/August 2017.

基于FDA在2017年7/8月的检查情况，FDA于2017年12月5日签发了对中国药品生产商汕尾泓汇日用品公司的警告信。

The company failed to check all batches of themanufactured drug product for compliance with the specifications.

该公司未对其所生产的所有批次药品进行检查以确定其符合质量标准。

It became apparent during the inspection that incomingactive pharmaceutical ingredients and excipients were not tested for identityupon entry. The company instead relied on the supplier's certificates ofanalysis. However, those had not been qualified.

在检查中，很明显进厂原料药和辅料均未在进厂时检查其鉴别，该公司只是依赖于供应商的COA。但是，这些COA都未经确认。

Shanwei Honghui had not verified the analysis results fromthesupplier'scertificates. There was no adequate validation in the formof checking the supplier's analysis results in regular intervals.

汕尾泓汇并未核对供应商COA上的分析结果。未定期检查供应商的分析结果来进行足够的验证。

In their response to the FDA on 23 August, 2017, ShanweiHonghui named a lack of experience with the FDA as a reason for this. Theresponse is described as inadequate and not detailed enough in the FDA warningletter.

在其2017年8月23日对FDA的回复中，汕尾宏汇说这是因为他们没有FDA经验。在FDA的警告信中，该回复被认为是不充分的，不够详细。

As a consequence, the FDA now placed the company on Import Alert.

由此，FDA现在将该公司放进了进口禁令清单。

Further details are available in the complete FDA Warning Letter issued to Shanwei Honghui Daily ApplianceCo. Ltd.

岁寒三友

感谢分享

赤脚天使

没有FDA经验，哈哈

Backey

权限不够，很想学习学习。

Ghou

日用品公司做药品？

414880245

很奇怪，日用品公司做的什么药呢