FDA 483 - Peter R. Movilla, MD - March 19, 2026

An FDA inspection of Peter R. Movilla, MD in Newton, MA, a clinical investigator, revealed significant deviations from an investigational plan and IRB conditions. The observations included failures to complete required procedures before subject enrollment, improper informed consent by unlicensed personnel, incorrect subject randomization, and inadequate data collection for the primary effectiveness endpoint. These issues indicate a lack of adherence to clinical trial protocols and regulatory requirements.