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类别: SAFETY SURVEILLANCE
FDA警告信
FDA向制造商发出的正式通信，表明存在重大法规违规。警告信通常引用GMP缺陷、标签违规或销售未经批准的器械。它们公开发布在FDA网站上。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
An FDA warning letter notifies a firm of significant violations and requests prompt corrective action; it is publicly posted and signals elevated compliance risk.
PROCESS / STEPS
- Parse cited regulations and products.
- Contain product risk if needed.
- Execute systemic CAPA and communicate to FDA.
- Verify sustainability before close-out.
EXAMPLES
- QS regulation failures and MDR reporting gaps are common warning-letter themes for device firms.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to FDA警告信 across 27 authorities in real time.
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