West Duluth Distribution Company – FDA 483, Sep 8, 2016

West Duluth Distribution Company Dba Chk Nutrition in Duluth, MN, an own label dietary supplement distributor, was inspected and received a Form 483 with eight observations. The inspection revealed significant deficiencies in quality control, record-keeping, and procedural documentation related to the manufacturing, testing, and handling of amino acid based dietary supplements. These issues indicate a lack of adequate controls to ensure product quality and compliance with established specifications.