483
Genovefa A Papanicolaou, MDGenovefa A Papanicolaou, MD – FDA 483, Jan 27, 2021
Record Details
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.
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