# FDA WARNING_LETTER - BTS S.p.A. - February 02, 2012

Source: https://www.globalkeysolutions.net/records/warning_letter/bts-spa/c7dcac10-8d4d-4619-90aa-8f997ec8b131

> FDA WARNING_LETTER for BTS S.p.A. on February 02, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: BTS S.p.A.
- Inspection Date: 2012-02-02
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On January 30 - February 2, 2012, an FDA inspection of BTS S.p.A. in Padova, Italy, found that their FreeEMG and PocketEMG devices were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's February 14, 2012, response to the FDA 483 was deemed inadequate for most observations.

Key violations include:
1.  **Design Validation (21 CFR 820.30(g))**: Failure to document design validation results (e.g., dates, personnel, and adherence to protocols) for the FreeEMG. The firm re-performed tests but lacked systemic corrective action.
2.  **Design Review (21 CFR 820.30(e))**: Failure to plan and document formal design reviews at appropriate stages. Procedures were amended, but systemic corrective action was not demonstrated.
3.  **Complaint Handling (21 CFR 820.198(a)(3))**: Inadequate procedures for evaluating complaints for Medical Device Reporting (MDR) reportability. Procedures were revised, but employee training and review of past complaints for MDR were not evidenced.
4.  **Acceptance Activities (21 CFR

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/bts-spa/8bd0b95b-cd2e-43b5-92e4-73671cdcb6ec

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