FDA WARNING_LETTER - American Contract Systems - January 14, 2011

On January 5-14, 2011, an FDA inspection of American Contract Systems in Tiffin, OH, revealed that the firm's custom convenience surgical kits are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. 352(t)(2).

Key violations include: 1. **Failure to adequately validate processes (21 CFR 820.75(a))**: * Ethylene Oxide sterilization method not fully validated; no documented evidence that all ~800 devices can withstand re-sterilization or that product integrity/functionality is not compromised. The firm's response regarding "industry knowledge" and "Component Evaluation form" was deemed inadequate. * No documented evidence that products tested for residuals were "worst case scenario." The firm's claims of past 2X sterilization experiments and analysis of EO delivery were not accepted as adequate. * Sterilization bag thickness tolerances (b)(4) not validated. The firm's response citing historical data and future monitoring was deemed insufficient without documented corrective action. * No documented stability testing to support expiration dates for kits. The firm's response about ongoing shelf-life testing and a 9