What is Form 483?

Form 483

What is Form 483?

Form 483 that is officially titled, Notice of Inspectional Observations, is used by U.S. Food and Drug Administration (FDA) during inspection of pharmaceutical manufacturing plants. The form lists all observations made by FDA inspectors regarding deviations from current Good Manufacturing Practices (cGMP).

When is Form 483 issued?

Form 483 is issued after an FDA inspection when there are violations of cGMP and other regulations.

What information does Form 483 contain?

Form 483 contains observations of cGMP and other regulatory violations noted by FDA inspectors. It describes all deviation from established procedures and practices and references of the violated regulations.

What should a company do upon receiving Form 483?

When a company receives Form 483, they should carefully review the observations noted by the FDA inspectors and promptly respond with corrective actions and preventive measures.