483
James Whitlock, M.D.FDA 483 - James Whitlock, M.D. - April 06, 2023
Record Details
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.
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ID · 73c2a6cc-bd7a-49e4-bdc5-d29edcb50920