FDA Inspection – Exit Interview and Form 483

The FDA inspection ends with an exit interview and that interview, coincidentally sealing the fate of the inspection company. In this exit interview, the FDA letter submits a written report of its inspection, followed by a debriefing. 

The report presented in the exit interview is designed primarily for FDA internal use and is non-permissible to view inspection company reports. For more information about fda 483 letter visit https://wizmed.com/fda-warning-letters.

FDA Inspection

If it is not complied with, the investigator at the end of the investigation issues a report against the company that mentions GMP violations and regulatory discrepancies that occur during the investigation. This report is commonly referred to as FDA Form 483 or "Notice of Informational Inspection".

However, the form only contains observations pertaining to the violation of the rules, not any suggestions, recommendations, opinions of the inspector.

Management can state the conditions they want to take to correct the situation or they can leave investigator comments. Form 483 should include only those comments that may be directly linked to a violation of the rules — not suggestions, guidance, or other comments of the person conducting the investigation.

Although, 483 does not include references to regulations, each observation must be traced directly to a portion of the applicable regulations.