FDA 483 - Mikell Jaratt, M.D. - February 24, 2022

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.