FDA 483 - American Contract Systems, Inc. - March 02, 2022

American Contract Systems, Inc. in Kansas City, MO, received a Form FDA 483 with four repeat observations during an inspection of its medical device manufacturing and sterilization facility. The firm was cited for significant deficiencies including inadequate process validation for the sterilization of custom surgical kits, ineffective corrective and preventive action procedures, a lack of established design controls, and insufficient employee training. These issues collectively point to systemic failures within the firm's quality management system.