Dr. Wilson Jacob-Filho – FDA Inspection, May 12, 2017

Record Details

This FDA Inspection record concerns Dr. Wilson Jacob-Filho, with an inspection on May 12, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company: Dr. Wilson Jacob-Filho
Inspection Date: May 12, 2017
Product Type: Biologics
Office: Center for Biologics Evaluation and Research
Person: Tara K. Carmody (FDA Associated Person)

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ID · b538644c-2636-46fc-9a18-36bdcc740833

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1012617
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

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FDA Inspection

Dr. Wilson Jacob-FilhoMay 12, 2017