FDA 483 - Robert G. Szewc MD - July 01, 2021

The FDA inspected Robert G. Szewc MD, a clinical investigator in San Antonio, TX, and found significant issues with clinical trial conduct. The firm failed to follow the investigational plan, resulting in incorrect dosing for multiple subjects. Additionally, serious adverse events, including three deaths, were not reported to the sponsor within the required 24-hour timeframe, and IRB reporting dates were often missing.