FDA 483 - American Contract Systems, Inc. - May 24, 2018

American Contract Systems, Inc. in Kansas City, MO, a contract sterilizer, manufacturer, and repackager/relabeler, was inspected and cited for multiple quality system deficiencies. Observations included inadequate procedures for non-conforming product control and in-process product acceptance, insufficient documentation of acceptance activities, and issues with quality audit independence. Furthermore, the firm failed to establish an adequate organizational structure per 21 CFR 820 and did not report a recall of a banned medical device to the FDA.