FDA 483 - CAO Group, Inc. - May 07, 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.