# FDA WARNING_LETTER - Lucero Medical, LLC - November 22, 2011

Source: https://www.keypedia.com/records/warning_letter/lucero-medical-llc/a5fba76e-bab8-4a26-8dab-780d09dd6391

> FDA WARNING_LETTER for Lucero Medical, LLC on November 22, 2011. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Lucero Medical, LLC
- Inspection Date: 2011-11-22
- Product Type: Devices
- Office Name: Cincinnati District Office
- Summary: 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

## Related Officers

- [District Director](https://www.keypedia.com/people/paul-j-teitell/5de80a65-d370-4a60-8080-21befa356d9b)

Company: https://www.keypedia.com/companies/lucero-medical-llc/8b5555fb-aacf-4ec8-aaaf-6ced1bfc9915

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22