483
Qun XiaQun Xia – FDA 483, Feb 20, 2025
Record Details
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.
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