SMT-Schilling Metalltechnik GmbH – FDA Warning Letter, Jul 19, 2012

On October 9, 2012, the FDA issued a Warning Letter to SMT-Schilling Metalltechnik GmbH following a July 16-19, 2012 inspection in Muhlheim, Germany. The inspection found that the firm's Class II K/Guide Wires were 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) for failing to furnish required information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting - MDR).

Key violations included: 1. **CAPA (21 CFR 820.100(a)):** Failure to establish and maintain adequate CAPA procedures, including investigation of non-conformances and analysis of quality data. The firm's response was deemed adequate for this point. 2. **Design Control (21 CFR 820.30(a)):** No procedures or documentation for design control (planning, inputs, outputs, reviews, verification, validation, transfer) for the K-Wire/Guide Wire design project. Response was inadequate. 3. **Purchasing Controls