FDA 483 - William E. Sanchez, M.D. - December 22, 2021

William E. Sanchez, M.D., a clinical investigator in Miami Lakes, FL, was inspected from December 7-22, 2021. The inspection revealed significant deviations from the investigational plan, including incorrect investigational product dose titration and administration, and providing investigational product before verifying subject inclusion criteria. Additionally, the firm failed to promptly report a serious adverse event to the study sponsor.