CAO Group, Inc. – FDA 483, May 7, 2018

An FDA inspection of CAO Group, Inc. in West Jordan, UT, revealed severe deficiencies in the conduct and oversight of an investigational device study. The firm initiated a clinical trial without required FDA and IRB approvals, failed to select qualified investigators, and neglected to maintain essential study records. These observations highlight a significant lack of adherence to regulatory requirements for medical device clinical investigations.