FDA 483 - James W. Findling, M.D. - August 26, 2021

An FDA inspection of James W. Findling, M.D. in Milwaukee, WI, a clinical investigator, revealed a significant failure in ensuring proper Institutional Review Board (IRB) oversight. The study site failed to submit a revised protocol, which included additional subject safety assessments, for IRB review and approval, resulting in subjects continuing the study under an outdated protocol. This indicates a serious lapse in regulatory compliance regarding clinical study management and subject protection.