FDA Form 483
What is FDA Form 483?
A document issued by FDA investigators at the end of an inspection listing observed conditions that may violate the Food Drug and Cosmetic Act.
Why does FDA Form 483 matter?
Form 483 is the document FDA inspectors hand to facility management at the conclusion of an inspection. It lists specific observations — not violations, but conditions that *may* constitute violations of FDA regulations.
Companies typically have 15 business days to respond in writing. Failure to respond adequately can escalate to a Warning Letter, consent decree, or even facility shutdown.
The name "483" comes from the form number. It's the most dreaded piece of paper in pharmaceutical manufacturing. A single Form 483 can tank a company's stock price, delay drug approvals, and trigger years of remediation.
Common 483 observations include data integrity failures, inadequate cleaning validation, equipment maintenance gaps, and failure to follow written procedures.
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