FDA 483 - Tory P. Sullivan, M.D., P.A. - March 03, 2023

An FDA inspection of Tory Sullivan, M.D., P.A. in North Miami Beach, FL, revealed significant deficiencies in the conduct of clinical investigations. The firm failed to follow its investigational plan, including not completing required efficacy endpoint questionnaires and assessments for multiple subjects. Additionally, the firm did not maintain accurate case histories, with numerous instances of missing or inconsistent documentation for study procedures and subject data.