483
Prof. Marek HusProf. Marek Hus – FDA 483, May 9, 2025
Record Details
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.
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