FDA 483 - James Whitlock, M.D. - April 06, 2023

An FDA inspection of James Whitlock, M.D., a clinical investigator in Toronto, revealed failures to conduct investigations in accordance with the investigational plan. Specifically, the firm was cited for under-reporting and late reporting of serious adverse events for subjects enrolled in a sponsored clinical protocol. These issues included misclassifying a grade 3 pancreatitis as grade 2 and submitting an expedited adverse event report beyond the protocol's allotted timeframe.