FDA 483 - Nina Gentile M.D - May 27, 2022

An FDA inspection of Nina Gentile M.D. in Philadelphia, a clinical investigator, revealed a significant issue regarding the timely reporting of serious adverse events (SAEs). The firm failed to conduct investigations in accordance with the investigational plan, specifically by not reporting two subjects' SAEs within the required timeframe as stipulated by the study protocol. This indicates a lapse in adherence to clinical trial protocols and patient safety reporting.