FDA 483 - James K. Luu, MD - December 18, 2020

James K. Luu, MD, a clinical investigator in Colorado Springs, CO, was cited for failing to conduct an investigation in accordance with the investigational plan. The inspection revealed that Dr. Luu, as Principal Investigator, did not provide adequate oversight of study personnel. This led to primary endpoint measurements being conducted by non-certified personnel, a direct violation of the study protocol's certification requirements.