FDA 483 - Vladmir M. Kushnir, MD - September 26, 2025

Washington University, a clinical investigator in Saint Louis, MO, received a Form FDA 483 following an inspection from September 22-26, 2025. The inspection revealed that an investigation for clinical trial TRL-1000-0007 was not conducted according to the investigational plan. Specific issues included failure to exclude subjects based on criteria, repeated prescription of prohibited therapies, and unreported adverse events.