FDA 483 - Tim Smith, M.D. - December 10, 2024

An FDA inspection of Tim Smith, M.D., a clinical investigator in Cincinnati, OH, revealed significant deviations from protocol and regulatory requirements. The firm failed to conduct an investigation in accordance with the signed agreement and investigational plan. Specifically, investigational product was not stopped for a subject despite exceeding stopping criteria, and a serious adverse event involving suicidal ideation was not reported.