FDA 483 - Mark Dacey, M.D. - November 08, 2024

Mark S. Dacey, M.D. in Denver, CO, was cited for significant deficiencies in clinical investigation practices, primarily concerning informed consent, adherence to investigational plans, and the maintenance of accurate case histories. The inspection revealed multiple instances where subjects were not properly consented, and protocols were not followed. Data discrepancies were prevalent, indicating a serious lack of oversight in clinical trial conduct.