Gabrielsen, Alvin A., Jr., M.D. – FDA Inspection, Oct 24, 2016

Record Details

This FDA Inspection record concerns Gabrielsen, Alvin A., Jr., M.D., with an inspection on October 24, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company: Gabrielsen, Alvin A., Jr., M.D.
Inspection Date: October 24, 2016
Product Type: Biologics
Office: Center for Biologics Evaluation and Research
Person: Stephen T. Hansen (Company Rep)

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ID · 6da351b9-39d9-4d31-872c-88e48f61a7ab

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 990084
FDA center: Biologics
Project area: Bioresearch Monitoring
Outcome: Form 483 issued

FDA Citations

21 CFR 312.60FD-1572, protocol compliance
21 CFR 312.62(b)Case history records- inadequate or inadequate

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FDA Inspection

Gabrielsen, Alvin A., Jr., M.D.October 24, 2016