FDA 483 - Genovefa A Papanicolaou, MD - January 27, 2021

An FDA inspection of Genovefa Papanicolaou, M.D., Clinical Investigator in New York, NY, revealed a significant failure to maintain adequate and accurate case histories. Specifically, the investigator did not document the precise time of study drug administration for 8 out of 12 subjects, preventing a determination of protocol compliance for required electrocardiograms. This indicates serious deficiencies in clinical trial documentation practices.