FDA 483 - Qun Xia - February 20, 2025

An FDA inspection of Qun Xia, Chief Physician, identified a significant failure in protecting human subjects during a clinical investigation. The site failed to obtain proper informed consent from four subjects who continued participation in a study, including receiving study-related procedures and assessments, despite refusing to sign an amended consent form. This lapse indicates a serious disregard for subject rights and safety.