FDA 483 - American Contract Systems, Inc. - September 10, 2019

An FDA inspection of American Contract Systems, Inc. in Kansas City, MO, a manufacturer, repackager/relabeler, and contract sterilizer, revealed significant deficiencies in their quality system. The inspection cited repeat observations regarding inadequate procedures for controlling non-conforming products, establishing acceptance activities, and managing employee training. These findings suggest a systemic failure to maintain proper quality controls.