FDA WARNING_LETTER - Shippert Medical Technologies - January 28, 2013

This FDA Warning Letter to Shippert Medical Technologies, dated July 18, 2013, details significant Current Good Manufacturing Practice (CGMP) violations of the Quality System (QS) regulation (21 CFR Part 820) for their Lipoplasty Suction System units, specifically the Tissu-Trans Filtron products. An inspection from January 9-28, 2013, revealed these devices are adulterated.

Key violations include: - **Process Validation (21 CFR 820.75(a)):** Failure to validate the sterilization process and injection molding process for Tissu-Trans Filtron products, despite design differences from previously validated products and use of a contract manufacturer. - **Design Validation (21 CFR 820.30(g)):** Inadequate documentation of design validation results and lack of a validation protocol for Tissu-Trans Filtron, despite obtaining a new 510(k) approval. - **Design Verification (21 CFR 820.30(f)):** No documentation to confirm design outputs met design inputs for Tissu-Trans Filtron. - **Risk Analysis (21 CFR 820.30(g)):** Incomplete risk analysis for Tissu-Trans Filtron, failing to evaluate risks associated with reported failure modes like leaking canisters, cracked lids, or foreign debris. - **Corrective and