# FDA WARNING_LETTER - TMS International - September 12, 2012

Source: https://www.keypedia.com/records/warning_letter/tms-international/1e5c3d63-486b-42cd-ab71-7c13e90a14e7

> FDA WARNING_LETTER for TMS International on September 12, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: TMS International
- Inspection Date: 2012-09-12
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: On December 13, 2012, the FDA issued a Warning Letter to TMS International in Oldenzaal, Netherlands, following an inspection from September 11-12, 2012. The inspection determined that TMS International manufactures Mind Media BV Biofeedback Devices, which are considered adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include:
1.  **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: The firm's CAPA procedure did not include all quality data sources of nonconformance, lacked criteria for follow-up issues, and did not fully describe investigation, implementation, verification, or documentation of CAPAs. The firm provided draft revisions, but no evidence of implementation.
2.  **Failure to document CAPA activities and results (21 CFR 820.100(b))**: A corrective action was implemented for damaged devices without documentation of the investigation or the implementation itself.
3.  **Failure to control nonconforming product (21 CFR 820.90(a))**: Procedures did not describe how nonconforming product would be identified, segregated, marked, or how its ultimate disposition would be documented.

The FDA deemed

## Related Officers

- [President](https://www.keypedia.com/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)

Company: https://www.keypedia.com/companies/tms-international/fa0d4769-ca0e-423a-a57d-0ec9f5d7c65c

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861