FDA 483 - Zsolt Szabo, M.D. - November 22, 2019

An FDA inspection of Zsolt Szabo, M.D., a sponsor investigator in Baltimore, MD, revealed significant deficiencies in the conduct and oversight of a clinical study. Observations included failure to adhere to protocol inclusion criteria for enrolled subjects, inadequate study monitoring, and unreported protocol deviations to the Institutional Review Board. These findings indicate a lack of proper controls in clinical trial management.