Lynn Malec, M.D. – FDA Inspection, Jan 8, 2024

Record Details

This FDA Inspection record concerns Lynn Malec, M.D., with an inspection on January 8, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company: Lynn Malec, M.D.
Inspection Date: January 8, 2024
Product Type: Biologics
Office: Center for Biologics Evaluation and Research
Person: Denise L. Burosh (FDA Associated Person)

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ID · e87965e2-5caa-438c-b5db-d9c9c99b5d47

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1226661
FDA center: Biologics
Project area: Bioresearch Monitoring

FDA Citations

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

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FDA Inspection

Lynn Malec, M.D.January 8, 2024