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

Source: https://www.globalkeysolutions.net/records/483/peter-james-ostler-md/c02d4126-c774-40cb-bf1a-45ff4db094c7

> FDA 483 for Peter James Ostler, MD on August 22, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Peter James Ostler, MD
- Inspection Date: 2025-08-22
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Officers

- [Dawn C. Olenjack](https://www.globalkeysolutions.net/people/dawn-c-olenjack/b5a18d10-cd4b-405e-9016-8f5274a33000)

Company: https://www.globalkeysolutions.net/companies/peter-james-ostler-md/0766b8c4-31ba-45d2-93dc-5385006e23b0

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8