FDA WARNING_LETTER - Vipamat Technologie - January 27, 2011

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