FDA 483 - HEATHER R. HARRISON, D.O. - September 19, 2018

An FDA inspection of HEATHER R. HARRISON, D.O. in Orem, UT, a clinical investigator, revealed significant deficiencies in the conduct of a clinical trial for postpartum depression. Observations included failures to follow the investigational plan, maintain accurate case histories, and adequately manage investigational drug disposition records. These issues indicate a lack of proper oversight and adherence to regulatory requirements for clinical studies.