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What are the difference between FDA 483 and Warning Letter?
27 Mar 2020

What are the difference between FDA 483 and Warning Letter?

483 observation or FDA 483 and warning letter seems to be same, nut there is difference between the FDA form 483 and Warning Letter. Let us understand the difference between the two.

FDA 483’s Warning Letter
The Form 483 is issued for inspectional observations. It lists the alleged deficiencies or issues of non-compliance in the manufacturer’s quality system. Warning letters are issued for violations of “regulatory significance”

(Significant violations are those violations that may lead to enforcement action if not promptly and adequately corrected).

The Form 483 is issued by the inspection team alone.


The warning letter is issued from a higher level FDA official or officials.


Bad inspections lead to Form 483s. Warning letters usually result from multiple lacking responses to issued 483s, or other issues much more serious that require quick attention/escalation.


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