Lucero Medical, LLC – FDA Warning Letter, Nov 22, 2011

On November 15-22, 2011, an FDA inspection of Lucero Medical, LLC, a specification developer and distributor of the Enduramesh spinal vertebral replacement device, revealed significant violations. The Enduramesh device was deemed 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 furnish required information under Medical Device Reporting (MDR) (21 CFR Part 803).

Key violations include: 1. **Design Control (21 CFR 820.30(a)):** No procedures for design control, initial design, or design change control for Enduramesh. 2. **CAPA (21 CFR 820.100(a)):** No procedures for corrective and preventive actions. 3. **Complaint Handling (21 CFR 820.198(a)):** No procedures for receiving, reviewing, and evaluating complaints. 4. **Purchasing Controls (21 CFR 820.50):** No procedures or controls for purchased products/services, specifically for the Enduramesh supplier. 5. **Acceptance Activities (2