FDA 483 - Maryellen Fitzgerald, M.D. - March 10, 2023

An FDA inspection of Maryellen Fitzgerald, M.D. in Watertown, MA, from March 7-10, 2023, identified a significant deviation from the investigational plan. The firm failed to conduct the study according to protocol, specifically regarding subject visit scheduling and laboratory sample collection. This resulted in multiple subjects having critical study visits performed outside the defined windows, indicating issues with clinical trial conduct.