FDA 483 - Michael C. Heinrich, M.D. - August 16, 2019

An FDA inspection of Michael C. Heinrich, M.D. in Portland, OR, a clinical investigator, revealed significant deficiencies in clinical trial conduct. Observations included failures to ensure informed consent was understandable for non-English speaking subjects and deviations from the investigational plan. These deviations involved enrolling a subject with exclusionary criteria and missing required ECG assessments, indicating a lack of adherence to regulatory requirements for human subject protection and study integrity.