FDA 483 - Aditya Bardia, M.D. - February 08, 2021

An FDA inspection of Aditya Bardia, M.D. in Boston, MA, a clinical investigator, revealed that an investigation was not conducted in accordance with the investigational plan. Specifically, subjects were not enrolled according to protocol criteria regarding prior chemotherapy, and required scans were taken outside of the specified timeframe. These findings indicate a significant deviation from the study protocol.