FDA 483 - Mark Roschewski, M.D. - May 11, 2021

Mark Roschewski, M.D., a clinical investigator in Bethesda, MD, was cited for failing to conduct an investigation in accordance with the signed statement of investigator and investigational plan. This involved two protocols where patients at moderate or high risk did not receive required monitoring or treatments, leading to severe adverse events, including a patient's death. The inspection revealed significant deviations from established protocols, raising concerns about patient safety and study integrity.