FDA 483 - Maria L. Colavincenzo, M.D. - March 10, 2022

An FDA inspection of Maria L. Colavincenzo, M.D. in Chicago, IL, revealed significant deficiencies in the conduct of clinical investigations. Observations included failures to adhere to the investigational plan, such as issues with subject inclusion criteria, incorrect investigational product dispensing, and not performing protocol-required tests. Additionally, the firm failed to maintain adequate and accurate case histories for subjects.