FDA 483 - CAO Group, Inc. - June 05, 2019

An FDA inspection of CAO Group, Inc., a medical device manufacturer in West Jordan, UT, revealed significant deficiencies in their quality system. Observations included inadequate procedures for complaint handling, device history record maintenance, corrective and preventive actions, incoming product acceptance, and personnel training documentation. These issues indicate a need for improved adherence to regulatory requirements for medical device manufacturing.