# FDA WARNING_LETTER - Zeppessis Reprocessing, LLC - April 11, 2013

Source: https://www.globalkeysolutions.net/records/warning_letter/zeppessis-reprocessing-llc/9b151527-3004-4579-9fe0-0f2e5d7bcf25

> FDA WARNING_LETTER for Zeppessis Reprocessing, LLC on April 11, 2013. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Zeppessis Reprocessing, LLC
- Inspection Date: 2013-04-11
- Product Type: Devices
- Office Name: Seattle District Office
- Summary: On April 8-11, 2013, an FDA inspection of Zeppessis in Garden City, Idaho, revealed that the firm reprocesses Stryker Neptune 1 and 2 Waste Management System manifolds, which are considered adulterated devices under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include:
- **Process Validation (21 CFR 820.75(a)):** Failure to validate the 7-step cleaning protocol, the use of industrial degreaser and Cidex OPA-C for manual reprocessing, and the addition of a non-original rubber o-ring. The firm's response regarding functional validation of the reflux prevention valve and new cleaning products was inadequate.
- **Complaint Files (21 CFR 820.198(a)):** Failure to document a complaint about an oversized o-ring causing a manifold to jam. The submitted procedure lacked required information, including reportability evaluation and device identification.
- **Corrective and Preventive Action (CAPA) (21 CFR 820.100(a)):** Failure to investigate a Bacillus count exceeding specifications, identify corrective actions, or verify effectiveness. The CAPA procedure was incomplete.
- **Production Process Control (21 CFR 820

## Related Officers

- [Celeste M. Corcoran](https://www.globalkeysolutions.net/people/celeste-m-corcoran/f34a3ac4-d0f5-4346-abb4-278ce1221cda)

Company: https://www.globalkeysolutions.net/companies/zeppessis-reprocessing-llc/e3fbf979-caba-427a-a3a8-22841af64737

Office: https://www.globalkeysolutions.net/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913