TMS International – FDA Warning Letter, Sep 12, 2012

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