FDA 483 - Giacomina Massaro-Giordano M.D. - March 09, 2018

Giacomina Massaro-Giordano M.D. in Philadelphia, PA, a clinical investigator, was cited for significant deficiencies during an FDA inspection. Observations included failure to conduct an investigation according to the investigational plan, specifically regarding subject eligibility and incomplete scheduled assessments. Additionally, the firm failed to maintain adequate and accurate case histories, with issues such as late signatures on assessments and numerous corrections in medication logs.