FDA 483 - Mikell Jaratt, M.D. - February 24, 2022
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An FDA inspection of Mikell Jaratt, M.D. in Gastonia, NC, from February 14-24, 2022, identified a critical failure in reporting unanticipated problems to the Institutional Review Board (IRB). The clinical investigator did not promptly notify the IRB about a study subject's multiple hospitalizations and concurrent medication, despite discovering the issue over a month prior to notification. This lapse indicates a significant deviation from human subject protection protocols.
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ID · f9ce38f1-d49d-49e7-8a7e-ff295dff6074