FDA 483 - Daniel H. Ahn D.O. - September 22, 2023

During an inspection from September 18-22, 2023, the FDA issued a Form 483 to Daniel H. Ahn D.O., a clinical investigator in Phoenix, AZ. The inspection revealed a significant deviation from protocol, as the clinical investigation was not conducted in accordance with the signed statement of investigator and investigational plan. This included failures to complete required ECGs and Hematology/Chemistry labs for multiple subjects across various cycles.