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类别: QUALITY SYSTEMS
FDA 483表
FDA调查人员在设施检查结束时出具的检查观察表。483表列出可能构成FD&C法违规的情况。企业必须在15个工作日内回应。
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
FDA Form 483 lists inspectional observations when investigators observe conditions that may violate the FD&C Act and related regulations.
PROCESS / STEPS
- Receive and review observations promptly.
- Investigate root causes; prepare a thorough written response.
- Implement CAPA with effectiveness checks.
- Track to inspection classification outcomes (e.g., VAI/OAI).
EXAMPLES
- Incomplete CAPA responses to 483 observations can escalate to warning letters.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to FDA 483表 across 27 authorities in real time.
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