FDA 483 - James R. Corbett, M.D. - July 08, 2019

James R. Corbett, M.D. in Ann Arbor, MI, was inspected regarding their role as a Sponsor-Investigator. The inspection revealed significant deficiencies in informed consent, study monitoring, IRB oversight, case history maintenance, and investigational drug accountability. These issues indicate a severe lack of adherence to regulatory requirements for clinical investigations, including continuing to enroll subjects after IND termination.