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FDA Inspection – Exit Interview and Form 483

The FDA inspection concludes with an exit interview and this interview accidentally shuts down the fate of the company under investigation. During the exit interview, the FDA submitted a written report on the inspection, followed by an interrogation.

The reports presented in the Exit interview were primarily prepared for internal use by the FDA and the inspected company remained without permission to view the report. You can look for FDA 483 letter via

The inspection host, clerk and quality and production management must be present at the departure interview. Others can attend if necessary.

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As previously mentioned, investigators provide a written report during the interview. The agency assumes that as a medicine, depending on the industry niche, companies must comply with Good Manufacturing Practices (CGMP) regulations and consumer organizations must comply with the Safe Medical Devices Act (SMDA; 1990) and the Medical Reporting Regulations (MDR).

If it turns out that these regulations have not been complied with, the investigator will issue a report against the company at the end of the investigation, mentioning violations of GMP and regulatory inconsistencies identified during the investigation.

This report is known as FDA Form 483 or "Inspection Notice". However, the form only contains monitoring related to regulatory violations and does not contain suggestions, recommendations or opinions from the inspector.