FDA 483 - Michael Chung, M.D. - November 13, 2023

An FDA inspection of Michael Chung, M.D. in Lynwood, CA, conducted from October 30 to November 13, 2023, revealed significant deviations from clinical investigation protocols. The firm failed to conduct an investigation in accordance with the investigational plan, including issues with administering treatments, dosing, and subject enrollment criteria. Additionally, the firm did not promptly report an unanticipated problem, a study enrollment hold, to the Institutional Review Board.