# FDA 483 - Peter O'Donnell - January 19, 2017

Source: https://www.globalkeysolutions.net/records/483/peter-odonnell/17908b6f-2d3c-4151-9228-2ef3b4228770

> FDA 483 for Peter O'Donnell on January 19, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Peter O'Donnell
- Inspection Date: 2017-01-19
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of Peter O'Donnell in Chicago, IL, revealed significant non-compliance in the conduct of a clinical investigation. The site failed to promptly report serious adverse events to the sponsor and did not adhere to the investigational plan for subject follow-up and adverse event reporting. Additionally, the firm maintained inadequate and inaccurate case histories and failed to provide required financial disclosure statements in a timely manner.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/jennifer-c-adams/85608566-bd13-41d8-b86e-cc9111c7dfe5)

Company: https://www.globalkeysolutions.net/companies/peter-odonnell/85e8932a-e1b8-41b0-bb21-9a6dd98004f3

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669