Levin, Myron J., M.D. – FDA Inspection, Apr 21, 2017

Record Details

This FDA Inspection record concerns Levin, Myron J., M.D., with an inspection on April 21, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company: Levin, Myron J., M.D.
Inspection Date: April 21, 2017
Product Type: Biologics
Office: Center for Biologics Evaluation and Research
Person: Theressa B. Smith (Issuing Officer)

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ID · fc9a270d-4822-4cb1-807c-cdd249f4cb16

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1017421
FDA center: Biologics
Project area: Vaccines and Allergenic Products
Outcome: Form 483 issued

FDA Citations

21 CFR 312.60FD-1572, protocol compliance
21 CFR 312.62(b)Case history records- inadequate or inadequate
21 CFR 312.62(a)Accountability records
21 CFR 312.62(c)Record retention

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FDA Inspection

Levin, Myron J., M.D.April 21, 2017