Peter James Ostler, MDAugust 22, 2025

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

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Record Details

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.

Company: Peter James Ostler, MD
Inspection Date: August 22, 2025
Product Type: Drugs
Office: Office of Inspections and Investigations
Person: Dawn C. Olenjack

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ID · c02d4126-c774-40cb-bf1a-45ff4db094c7