GLOSSARYUS

Form 483

The list of observations an investigator from the FDA gives a firm's management at the end of an inspection. The list covers conditions that may violate the Federal Food, Drug, and Cosmetic Act. A Form 483 is not a final determination by the FDA that a violation exists.

Where it is written: FDA Form 483 Frequently Asked Questions
Also called: FDA Form 483, inspectional observations, 483

Avoid This Mistake

A Form 483 is not a final determination by the FDA that a violation exists. The form is also not a complete list: observations of questionable or unknown significance are left out.

Related terms

Warning Letter Adulterated

On this site

Few Form 483s Escalate to a Warning Letter

All Terms Run the Form 483 & Inspection Readiness Diagnostic