FDA 483 - Lixin Zhang, M.D. - December 19, 2025

An FDA inspection of Dent Neurosciences Research Center, a clinical investigator in Amherst, NY, revealed significant issues with the conduct of an investigation. The firm failed to follow the investigational plan, specifically regarding data integrity in an eCOA system where a common password allowed a subject to access staff accounts and enter data. Additionally, the site dispensed an incorrect dose formulation of investigational product to a subject.