FDA 483 - Bret R. Rutherford, M.D. - January 10, 2023

The New York State Psychiatric Institute received a Form 483 with three observations during an inspection from December 2022 to January 2023. The observations primarily concern failures in clinical trial conduct, including implementing changes without Institutional Review Board (IRB) approval, enrolling subjects who did not meet protocol criteria, and inadequate study monitoring. These issues indicate significant deviations from investigational plan requirements and proper oversight.