What is Form 483 in regulatory affairs?

Company X has received inspectional observations from the US Food and Drug Administration (FDA) for one of its active pharmaceutical ingredients (APIs) manufacturing plant. The observations came after a team of the US FDA visited the site. The Form 483 is a list of observations that the audit inspectors find objectionable at the plant and hand it out to the management. After receiving this, the company needs to reply in writing, within 15 days, giving a detailed plan of corrective action.

The USFDA typically inspects facilities, for pre-approval, compliance with current good manufacturing practices, or product specific approval. The FDA’s inspection team in India has around 20 people, who carry out ‘aggressive surveillance and surprise inspections.

The U.S. Food and Drug Administration (FDA) is authorized to perform inspections under the Federal Food, Drug, and Cosmetic Act, SEC. 704 (21 USC §374) “Factory Inspection”. Form FDA 483,“Inspectional Observations,” is a form used by the FDA to document and communicate concerns discovered during these inspections.

So Form 483 observation is lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance. 

A recipient of a 483 should respond to the FDA, addressing each item, indicating agreement and either providing a timeline for correction or requesting clarification of what the FDA requires.