Gerard Sanacora, MD, PhD – FDA Inspection, Sep 18, 2026

Record Details

This FDA Inspection record concerns Gerard Sanacora, MD, PhD, with an inspection on September 18, 2026, issued by the New England District Office, covering human drugs.

Company: Gerard Sanacora, MD, PhD
Inspection Date: September 18, 2026
Product Type: Human Drugs
Office: New England District Office
Person: Agata E. Libera (Issuing Officer)

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ID · c8498044-3064-40be-9fa1-b8fac3f2d950

Inspection Facts

Inspection number: 1338140
FDA center: Human Drugs
Project area: Bioresearch Monitoring
Outcome: Form 483 issued

FDA Citations

21 CFR 312.62(b)Case history records- inadequate or inadequate
21 CFR 50.27(a)Consent form not approved/signed/dated

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FDA Inspection

Gerard Sanacora, MD, PhDSeptember 18, 2026