FDA 483 - Rabi Hanna, M.D. - October 07, 2024

An FDA inspection of Clinical Investigator Rabi Hanna, MD at Cleveland Clinic in Cleveland, OH, identified two significant observations related to clinical trial conduct. The firm failed to promptly report a serious adverse event to the study sponsor and did not conduct the investigation in accordance with the approved protocol, specifically regarding the collection of required lab samples for a subject.