# FDA WARNING_LETTER - American Contract Systems - January 14, 2011

Source: https://www.keypedia.com/records/warning_letter/american-contract-systems/c8ef26f4-5390-4ca8-a5f1-dab296d5788a

> FDA WARNING_LETTER for American Contract Systems on January 14, 2011. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: American Contract Systems
- Inspection Date: 2011-01-14
- Product Type: Devices
- Office Name: Cincinnati District Office
- Summary: 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

## Related Officers

- [Scott Wiest](https://www.keypedia.com/people/scott-wiest/5c5c8ac7-1b67-416b-abdb-c059b6417fb6)
- [Teresa C. Thompson](https://www.keypedia.com/people/teresa-c-thompson/b41b98e5-2a7c-4f19-923b-058a197a8fd4)

Company: https://www.keypedia.com/companies/american-contract-systems/43618d94-7c9a-4822-97fc-8115b6600692

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22