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

Source: https://www.globalkeysolutions.net/records/warning_letter/somatex-medical-technologies-gmbh/f8fbbe69-3690-4981-9aa3-e3251bdb80e7

> FDA WARNING_LETTER for Somatex Medical Technologies GMBH on October 16, 2014. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Somatex Medical Technologies GMBH
- Inspection Date: 2014-10-16
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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'

## Related Officers

- [Christopher Hansche](https://www.globalkeysolutions.net/people/christopher-hansche/34d6f6df-7f12-4e1b-9cef-87c0ce6366a9)
- [Jan B. Welch](https://www.globalkeysolutions.net/people/jan-b-welch/65bfaf7c-7ce6-4c33-80bd-090efbf2eec5)

Company: https://www.globalkeysolutions.net/companies/somatex-medical-technologies-gmbh/5225948d-3741-46de-9643-9571e652d5ed

Office: https://www.globalkeysolutions.net/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7