Michael C. Heinrich, M.D. – FDA Inspection, Aug 16, 2019

Record Details

This FDA Inspection record concerns Michael C. Heinrich, M.D., with an inspection on August 16, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Michael C. Heinrich, M.D.
Inspection Date: August 16, 2019
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Mark W. Babbitt (Issuing Officer)

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ID · 64e3d9d4-52bf-4d21-bc48-c369bb360f52

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1099838
FDA center: Human Drugs
Project area: Bioresearch Monitoring
Outcome: Form 483 issued

FDA Citations

21 CFR 312.60FD-1572, protocol compliance
21 CFR 50.20Understandable language

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FDA Inspection

Michael C. Heinrich, M.D.August 16, 2019