483
Tyrone McCall, M.D.FDA 483 - Tyrone McCall, M.D. - September 19, 2022
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Record Details
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.
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ID · b3d18006-fde6-4e08-8135-998c83d12508