Dr. med. Harald Bruening – FDA Inspection, Dec 16, 2016

Record Details

This FDA Inspection record concerns Dr. med. Harald Bruening, with an inspection on December 16, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Dr. med. Harald Bruening
Inspection Date: December 16, 2016
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: James P. McEvoy (Company Rep)

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ID · a61b35d1-8cbd-43bf-91f4-ad14e39749d5

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 995734
FDA center: Human Drugs
Project area: Bioresearch Monitoring
Outcome: Form 483 issued

FDA Citations

21 CFR 50.27(a)Consent form not approved/signed/dated

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FDA Inspection

Dr. med. Harald BrueningDecember 16, 2016