FDA 483 - Alexander E. Horwitz, III, M.D. - November 14, 2014

An FDA inspection of Oregon Center of Clinical Investigations revealed significant deficiencies in the conduct of a clinical investigation. The firm failed to adhere to the investigational plan, including enrolling ineligible subjects and not promptly reporting protocol deviations or adverse events to the sponsor. Additionally, inaccuracies were found in the maintenance of case histories.