FDA WARNING_LETTER - Somatex Medical Technologies GMBH - October 16, 2014

On October 13-16, 2014, an FDA inspection of Somatex Medical Technologies GmbH in Teltow, Germany, revealed that their TUMARK Flex for Mammotome and biopsy system devices were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System regulation (21 CFR Part 820). The firm's November 4, 2014, response was deemed inadequate.

Violations included: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: The CAPA procedure lacked requirements for analyzing quality data sources, using statistical methodology, verifying/validating actions, and disseminating information. The firm revised the procedure but did not conduct a retrospective review. 2. **Failure to establish and maintain design validation procedures (21 CFR 820.30(g))**: The design validation procedure for Tumark Flex devices did not specify validation on initial production units under actual/simulated use conditions or establish acceptance criteria. The firm plans revisions but did not retrospectively review records. 3. **Failure to establish and maintain procedures for purchased product/service conformity (21 CFR 820.50)**: Supplier audits for major Tumark Flex component suppliers were not conducted for at least three years, despite the firm'