FDA 483 - Nikolaos T. Pyrsopoulos, M.D. - February 22, 2022

An FDA inspection of Nikolaos T. Pyrsopoulos, M.D. in Newark, NJ, a clinical investigator, identified significant deficiencies in the conduct of a Phase 2b study for Alcoholic Hepatitis. The firm failed to report adverse experiences to the sponsor, ensure proper staff training and delegation for study tasks including informed consent, and maintain accurate study records. These issues indicate a lack of adherence to regulatory requirements for clinical investigations.