FDA 483 - ARISTIDES MANIATIS, M.D. - March 02, 2021

An FDA inspection of Aristides Maniatis MD, a clinical investigator in Centennial, CO, revealed significant deficiencies in clinical trial conduct. Observations included inadequate investigational drug disposition records, with numerous missing drug vials, and a failure to report adverse events as required by the study protocol. These issues indicate a lack of adherence to regulatory requirements for clinical investigations.