FDA 483 - Ehrin J. Armstrong, MD - January 23, 2020

An FDA inspection of Ehrin J. Armstrong, MD, a clinical investigator in Aurora, CO, revealed a significant deviation from an investigational plan. Three subjects were improperly enrolled in a study and received an investigational device despite not meeting the protocol's eligibility criteria. This indicates a failure to conduct the investigation in accordance with the signed agreement and investigational plan.