FDA 483 - Frantisek Duska, M.D. - August 22, 2025

An FDA inspection of Frantisek Duska, M.D., a clinical investigator in Prague, Czechia, revealed significant deficiencies in the conduct of study protocol 995 AdFirst. Observations included failures to maintain complete source documentation for adverse events and to report some adverse events, as well as incorrect calculation of blood loss as outlined in the investigational plan. These findings indicate a lack of adherence to proper clinical trial practices.