Bret R. Rutherford, M.D.
Bret R. Rutherford, M.D.
New York State Psychiatric Institute
1051 Riverside Drive
New York , NY 10032-1007
United StatesFEI 3023259471Issued Mar 21, 2024Center for Drug Evaluation and Research | CDER
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3023259471.
Violations1
Issue DateMar 21, 2024
Product TypeOther
StatusOpen
Letter Details
Firm
Bret R. Rutherford, M.D.
Location
Bret R. Rutherford, M.D.
Bret R. Rutherford, M.D.
New York State Psychiatric Institute
1051 Riverside Drive
New York , NY 10032-1007
United States
FEI Number
3023259471
Country
United States
Issue Date
March 21, 2024
Issuing Office
Center for Drug Evaluation and Research | CDER
Product Type
Other
Status
Open
Summary
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.
Bret R. Rutherford, M.D. FDA Warning Letter, March 21, 2024
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