Patricia L. Norris, MD – FDA Inspection, Feb 10, 2017

Record Details

This FDA Inspection record concerns Patricia L. Norris, MD, with an inspection on February 10, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company: Patricia L. Norris, MD
Inspection Date: February 10, 2017
Product Type: Biologics
Office: Center for Biologics Evaluation and Research
Person: Sherri N. Rohlf (Company Rep)

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ID · 3a81a405-7a18-46c5-a2d9-e324424b8567

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1003694
FDA center: Biologics
Project area: Vaccines and Allergenic Products
Outcome: Form 483 issued

FDA Citations

21 CFR 312.60FD-1572, protocol compliance
21 CFR 312.66Initial and continuing review
21 CFR 312.62(b)Case history records- inadequate or inadequate

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FDA Inspection

Patricia L. Norris, MDFebruary 10, 2017