Dominique Paul Germain, M.D. – FDA Inspection, May 17, 2018

Record Details

This FDA Inspection record concerns Dominique Paul Germain, M.D., with an inspection on May 17, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Dominique Paul Germain, M.D.
Inspection Date: May 17, 2018
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Andrea A. Branche (FDA Associated Person)

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ID · c6535c8e-f569-4f22-a72a-88643061bfcc

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1052916
FDA center: Human Drugs
Project area: Bioresearch Monitoring
Outcome: Form 483 issued

FDA Citations

21 CFR 312.62(b)Case history records- inadequate or inadequate

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FDA Inspection

Dominique Paul Germain, M.D.May 17, 2018