FDA 483 - Mrinal M. Gounder, M.D. - March 03, 2023

Mrinal M. Gounder, M.D., a clinical investigator in New York, NY, received a Form FDA 483 with two observations during an inspection from February 21 to March 3, 2023. The inspection revealed failures to conduct investigations in accordance with the investigational plan, specifically regarding the timely submission of deviation reports. Additionally, the firm failed to promptly report serious adverse events to the sponsor, indicating significant non-compliance with clinical trial regulations.