FDA 483 - Angela M. Stupi, M.D. - September 29, 2022

An FDA inspection of Angela M. Stupi, M.D. revealed significant deviations in the conduct of clinical investigations. The firm failed to adhere to investigational plans and protocols regarding subject eligibility, screening, safety assessments, and study drug administration. Additionally, the firm did not maintain adequate and accurate case histories, leading to inaccurate reporting to the sponsor and missing documentation.