American Contract Systems, Inc. – FDA 483, Sep 10, 2019

An FDA inspection of American Contract Systems, Inc. in Kansas City, MO, a manufacturer, repackager/relabeler, and contract sterilizer, revealed significant and repeat deficiencies in their quality system. The firm failed to adequately control non-conforming products, properly establish acceptance activities for product release, and ensure employees were retrained on revised procedures. These repeat observations indicate persistent issues with the firm's compliance with quality system requirements.