Florence Lerebours, M.D. – FDA 483, Jun 18, 2026

An FDA inspection of Florence Lerebours, a clinical investigator in Saint-Cloud, France, revealed significant deficiencies in the timely reporting of adverse events and adherence to the investigational plan. The firm failed to promptly report serious adverse events to the sponsor, with delays ranging from 28 to 31 days. Additionally, investigations were not conducted according to the investigational plan, leading to delays of up to 103 days in reporting treatment emergent adverse events into the electronic data capture system.