FDA 483 - Cassius I. O. Chaar, M.D. - August 15, 2025

An FDA inspection of Cassius I. O. Chaar, M.D., a clinical investigator in New Haven, CT, revealed a significant issue with the timely reporting of Serious Adverse Events (SAEs). The firm failed to report 33.3% of SAEs within the protocol-mandated 10 days of awareness, with some delays extending over 900 days. This indicates a failure to adhere to investigational plan requirements.