FDA WARNING_LETTER - American Contract Systems, Inc. - August 14, 2024

An FDA inspection of American Contract Systems (ACS), Inc. in Tiffin, OH, from August 5-14, 2024, revealed that the firm's sterile convenience kits are adulterated under section 501(h) of the Act due to non-conformity with the Quality System regulation (21 CFR Part 820). The inspection identified three primary violations. First, ACS failed to establish and maintain procedures for incoming product acceptance (21 CFR 820.80(b)), evidenced by accepting sterilization bag lots that failed thickness requirements. Second, the firm failed to establish and maintain procedures for device design control (21 CFR 820.30(a)), specifically by not completing design verification and validation activities for 25 different FDA product codes and their components, such as those in the C-Section Pack. Third, ACS did not maintain complete design history files (DHFs) for these 25 product codes (21 CFR 820.30(j)). The firm's response dated September 5, 2024, was deemed inadequate, lacking sufficient detail on systemic preventive actions and the prioritization of DHF remediation. ACS must take prompt action to address these violations, provide a comprehensive response within fifteen business days detailing corrective actions, preventive measures, and a timetable for completion, or face potential regulatory actions including seizure, injunction, and civil money penalties.