Wael Garas, M.D. – FDA Inspection, Mar 15, 2024

Record Details

This FDA Inspection record concerns Wael Garas, M.D., with an inspection on March 15, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Wael Garas, M.D.
Inspection Date: March 15, 2024
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Courtney R. Bratina (Company Rep)

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ID · 7ecf8a67-b603-458f-ade4-8b18b21b825c

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1234200
FDA center: Human Drugs
Project area: Bioresearch Monitoring

FDA Citations

21 CFR 312.60FD-1572, protocol compliance
21 CFR 312.62(b)Case history records- inadequate or inadequate
21 CFR 312.64(b)Safety Reports - Non-Serious Events

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FDA Inspection

Wael Garas, M.D.March 15, 2024