FDA 483 - Lana M. Rifkin, M.D. - March 12, 2019

An FDA inspection of Lana M. Rifkin, M.D., a clinical investigator in Boston, MA, revealed a significant deviation from an investigational plan. The firm failed to conduct an investigation in accordance with its protocol, specifically by randomizing and completing the study with subjects who did not meet required inclusion/exclusion criteria. This indicates issues with adherence to study protocols and subject eligibility.