FDA 483 - Michael W. Harris, D.O. - December 15, 2015

An FDA inspection of Michael W. Harris, D.O., Clinical Investigator, in Orem, UT, revealed significant deviations from the investigational plan and inadequate record-keeping practices. The firm failed to properly assess and report serious adverse events, ensure subjects met screening criteria before enrollment, and report concomitant medications. Additionally, the investigator repeatedly backdated source documents, maintained inconsistent data, and mismanaged study records, highlighting severe data integrity issues.