FDA 483 - Peter James Ostler, MD - August 22, 2025

An FDA inspection of Peter James Ostler, MD, a clinical investigator in Northwood, Middlesex, United Kingdom, revealed a significant failure to adhere to study protocol requirements. The inspection found a pattern of not reporting non-serious adverse events to the sponsor in a timely manner. Specifically, at least 25 unreported adverse events were identified across five of the ten subject records reviewed for protocol CO-338-063.