FDA 483 - Ahmad (nmi) Shabsigh, MD - February 26, 2020

An FDA inspection of Ahmad (nmi) Shabzigh, MD, a clinical investigator in Columbus, OH, revealed significant deficiencies in the conduct of a clinical study. Observations included a failure to adhere to the investigational plan, specifically regarding repeat urine cytology testing and timely reporting of serious adverse events. Additionally, the firm failed to maintain adequate and accurate case histories, with instances of misrepresenting equivocal lab results as complete responses and other record discrepancies.