FDA 483 - Roy F. Chemaly - March 03, 2021

An FDA inspection of Roy F. Chemaly, a clinical investigator in Houston, TX, revealed a significant compliance issue related to clinical trial conduct. The firm failed to report serious adverse events (SAEs) to the study sponsor within the timeframes specified by the study protocols. This indicates a critical lapse in patient safety reporting and adherence to regulatory requirements for investigational drug studies.