FDA 483 - Carl P. Griffin, M.D. - November 17, 2023

An FDA inspection of Carl F. Griffin, M.D. in Oklahoma City, a clinical investigator, revealed a significant issue regarding the conduct of an investigation. Specifically, the firm failed to properly review, verify, and evaluate subject diary entries for unsolicited Adverse Events as required by the investigational plan and protocol. This indicates a lapse in adherence to established research procedures.