FDA 483 - Dennis M Marcus, M.D. - February 22, 2022

Dennis Marcus, M.D., a clinical investigator in Augusta, GA, was cited for significant deviations from an investigational plan during an FDA inspection. The inspection revealed that the investigation was not conducted according to the signed statement of investigator, with issues including the enrollment of ineligible subjects and a lack of proper training and documentation for study personnel. These findings indicate a failure to adhere to clinical trial protocols.