FDA 483 - Mark Roschewski, M.D. - April 15, 2024

Mark Roschewski, M.D. in Bethesda, MD, a clinical investigator, was inspected by the FDA from April 8-15, 2024. The inspection revealed that an investigation was not conducted in accordance with the signed statement of investigator and investigational plan. Specifically, subjects who screened positive for a core antibody did not receive required follow-up testing as outlined in the protocol.