# FDA WARNING_LETTER - Vipamat Technologie - January 27, 2011

Source: https://www.keypedia.com/records/warning_letter/vipamat-technologie/fd5aa63e-ff3c-4852-aff5-2e044674a6bd

> FDA WARNING_LETTER for Vipamat Technologie on January 27, 2011. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Vipamat Technologie
- Inspection Date: 2011-01-27
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On January 24-27, 2011, an FDA inspection of VIPAMAT Technologie S.a.R.L. in Ploemeur, France, revealed that their HIPPOCAMPE Special Grade Wheelchair, a Class II device, was adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to comply with Medical Device Reporting (MDR) regulations (21 CFR Part 803).

Key violations include:
1.  **Design Control (21 CFR 820.30(a)):** No established procedures for device design.
2.  **Design Changes (21 CFR 820.30(i)):** No procedures for documenting and approving design changes (e.g., seat material change due to flammability).
3.  **Design Review Documentation (21 CFR 820.30(e)):** Design inputs lacked documented review and approval.
4.  **CAPA (21 CFR 820.100(a)):** No established CAPA procedures, despite documented corrective actions.
5.  **Complaint Handling (21 CFR

## Related Officers

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

Company: https://www.keypedia.com/companies/vipamat-technologie/d41fea06-e10a-4aec-b221-dd5dfc8da954

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