FDA 483 - Alan G. Garscadden, M.D. - October 22, 2021

Alan G. Garscadden, M.D., a clinical investigator in Colorado Springs, CO, was cited for failing to conduct an investigation in accordance with the signed statement of investigator and investigational plan. Specifically, the investigator failed to follow protocol sections regarding inclusion/exclusion criteria for subjects and the proper administration of investigational product for protocol MMR-158. These deviations indicate significant non-compliance with clinical trial protocols.