FDA 483 - Pacific Medical Group, Inc. DBA Avante Health Solutions - September 24, 2021

Pacific Medical Group, Inc., a servicer/remanufacturer in San Clemente, CA, was cited for significant deficiencies in its quality system during an FDA inspection. The inspection revealed inadequate procedures for complaint handling, ineffective corrective and preventive actions, incomplete service reports, and a lack of control over non-conforming products. These issues indicate a systemic failure to ensure proper documentation and evaluation of device issues and repairs.