FDA 483 - Richard B. Powell, MD - May 24, 2023

Richard B. Powell, MD, a clinical investigator in Cincinnati, OH, was cited for significant deficiencies in conducting investigational studies. The inspection revealed failures to adhere to investigational plans, including incorrect subject dosing, out-of-window drug administration, and critical delays in reporting serious adverse events, including a subject's death. Additionally, the firm failed to maintain accurate case histories, with missing dosing records and unreported concomitant medications for multiple subjects.