FDA 483 - Kevin Stein, M.D. - April 23, 2025

An FDA inspection of Kevin Stein, M.D. in Winston Salem, NC, identified significant deviations in the conduct of a clinical investigation. The firm failed to adhere to the investigational plan and study protocol, specifically regarding the storage temperatures of investigational product and the performance of required events for study subjects. These findings indicate serious non-compliance in clinical trial management and subject safety.