# FDA WARNING_LETTER - SMT-Schilling Metalltechnik GmbH - July 19, 2012

Source: https://www.keypedia.com/records/warning_letter/smt-schilling-metalltechnik-gmbh/041244eb-f552-43f1-98cc-334ce271f758

> FDA WARNING_LETTER for SMT-Schilling Metalltechnik GmbH on July 19, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: SMT-Schilling Metalltechnik GmbH
- Inspection Date: 2012-07-19
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

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Company: https://www.keypedia.com/companies/smt-schilling-metalltechnik-gmbh/76372cd4-aa3a-4f92-855f-5a523d03efe5

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