FDA Exit Interview

Conducted at the end of every FDA inspection, an exit interview is the ultimate decider of the fate of the inspected company. In this exit interview, FDA presents a written report of its inspection, followed by a debriefing. Report presented in the exit interview is mainly prepared for the internal use of FDA and the inspected company remains non-permitted to see the report.

The exit interview should be attended by the inspection host, scribe, and senior management from both Quality and Manufacturing. Others may attend if appropriate. During exit interview, FDA organizes discussion with the management about the dos and don'ts of the manufacturing process and issues EIR (Establishment Inspection Report).

During the exit interview:

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• Ensure entire issues raised by the FDA investigators are clearly understood by you.
• Challenge to correct any errors in the findings.
• Note down observations, comments, and commitments made by both the parties involved in inspection.

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