FDA 483 - Sunandana Chandra, M.D. - June 16, 2021

An FDA inspection of Jeffrey A. Sosman, M.D., a clinical investigator in Chicago, IL, revealed significant deviations from the investigational plan. The firm failed to conduct the study in accordance with the protocol, specifically regarding subject enrollment, screening procedures, and required laboratory assessments. These failures resulted in subjects receiving investigational product without meeting inclusion criteria or having critical exclusion criteria properly evaluated.