FDA 483’s and Warning Letters


Your company has just been inspected by the US Food and Drug Administration (FDA) Office and the FDA inspectors handed over an FDA Form 483 at the end of the inspection. What does that mean for your company? Is this what they call the “FDA Warning Letter”?

This blog is about FDA Forms 483 (“FDA 483”) and Warning Letters, and how to deal with these documents.

Author: Henrieke de Bie, Principal Consultant, Rescop BV

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Source: Rescop.com