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. The firm failed to provide adequate oversight of its site management organization, resulting in issues with subject enrollment, protocol adherence, and personnel qualifications. Additionally, the inspection found widespread failures in maintaining accurate and complete case histories, informed consent documentation, and investigational drug disposition records.