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

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