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Dr. Bret R. Rutherford, a clinical investigator and sponsor at the New York State Psychiatric Institute, was cited for violations in the conduct of drug clinical investigations inspected between December 2022 and January 2023. The primary violation was failure to ensure that clinical investigations were conducted according to their investigational plans, in violation of 21 CFR 312.60 and applicable provisions of the Federal Food, Drug, and Cosmetic Act. The inspection, conducted under FDA's Bioresearch Monitoring Program, identified objectionable conditions related to human subject protection and adherence to research protocol requirements.