What is Form 483 in FDA audit

Question

Accepted Answer

Form 483 is a document issued by the FDA to notify a company of observed deviations from current Good Manufacturing Practices (cGMP).

Form 483 is issued after an FDA audit or inspection of a facility.
It lists the observations made by the FDA investigator regarding non-compliance with cGMP regulations.
The observations may include issues related to manufacturing processes, quality control, documentation, or facility maintenance.
Receiving a Form 483 does not necessarily mean that the FDA will take further regulatory action, but it indicates areas of concern that need to be addressed.
The company is required to respond to the observations in writing, explaining the corrective actions taken or planned.
Failure to adequately address the observations may lead to further regulatory action, such as warning letters or product recalls.

Accepted Answer

Those are observations of FDA during company audit

Popular interview questions of QA Manager