FDA 483 - Prof. Marek Hus - May 09, 2025

Prof. Marek Hus, a clinical investigator in Lublin, Poland, was cited for failing to adhere to an investigational plan during a clinical study. The inspection revealed multiple instances where subject dosing was not re-calculated according to protocol requirements, specifically concerning body weight changes. This indicates a significant deviation from the study's established procedures for patient treatment.