483
Zsolt Szabo, M.D.FDA 483 - Zsolt Szabo, M.D. - November 22, 2019
Record Details
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.
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ID · b0337d80-40ac-4bb7-9bb9-0687f25221b3