FDA 483 - John C. Lieske, M.D., Clinical Investigator - March 03, 2023

An FDA inspection of John C. Lieske, M.D., Clinical Investigator in Rochester, MN, revealed significant deficiencies in adverse event reporting. The firm failed to report serious adverse events, including those involving hospitalization, to the study sponsor as required by protocol. Additionally, non-serious adverse events were not reported to the sponsor in accordance with the study protocol's specified timetable.