FDA 483 - Tyrone McCall, M.D. - September 19, 2022

An FDA inspection of Tyrone McCall, M.D. in Dallas, TX, a clinical investigator, revealed a significant regulatory violation. The firm failed to submit an Investigational New Drug (IND) application to the FDA before conducting a clinical investigation. This unapproved study involved enrolling, randomizing, and treating sixty-nine subjects with an investigational new drug.