Frequently Asked Questions

How are clinical investigator inspections conducted?

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Clinical: Biopharma
Clinical: MedTech

FDA investigators must display his/her FDA credentials and issue a completed Form FDA 482 (Notice of Inspection) upon arrival. During the inspection, the FDA investigator willy verify compliance with the regulations governing the use of investigational products and human subject protections at 21 CFR parts 50, 56, 312, and/or 812 by inspecting records and talking to individuals involved in the conduct of the study.