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

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.