FDA警告信翻译站点

用途：FDA Warning Letters 用于查询 FDA 对企业、研究机构和产品合规问题发出的警告信。

适用场景：适用于 GMP、GCP、GLP、药品生产质量、数据完整性、临床试验合规和监管检查案例学习。

检索关键词：FDA 警告信、Warning Letter、GMP、GCP、数据完整性、现场检查、药品合规、质量管理。

FDA  Warning Letters

Learn about the types of warning letters on FDA’s website.

• Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter.
• To obtain additional available information, contact FDA. Requests to FDA for agency records should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5630 Fishers Lane, Rockville, MD 20857. Instructions for how to submit an FOI request can be found at How to Make a FOIA Request.

• FDA 警告信中描述的事项可能会受到 FDA 与信函收件人之间的后续互动的影响，这可能会改变信函中讨论的问题的监管状态。
• 要获得更多可用信息，请联系 FDA。向 FDA 提出的机构记录请求应发送至：Food and Drug Administration Division of Information (HFI-35), 5630 Fishers Lane, Rockville, MD 20857。有关如何提交 FOI 请求的说明可在How to Make中找到FOIA 请求。