# FDA WARNING_LETTER - Cagenix - August 16, 2011

Source: https://www.keypedia.com/records/warning_letter/cagenix/14584d82-7252-4c03-ad42-6c3c31384329

> FDA WARNING_LETTER for Cagenix on August 16, 2011. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Cagenix
- Inspection Date: 2011-08-16
- Product Type: Devices
- Office Name: New Orleans District Office
- Summary: On August 9-12 and 16, 2011, an FDA inspection of Cagenix, Incorporated, a manufacturer of Accuframe® dental bridge frameworks, revealed significant violations of the Quality System (QS) regulation (21 CFR Part 820). The Accuframe® devices were deemed adulterated under Section 501(h) of the Federal Food, Drug, and Cosmetic Act due to non-conformance with Current Good Manufacturing Practice (CGMP) requirements.

Key violations include:
1.  **Failure to establish and maintain design control procedures (21 CFR 820.30(a))**: Deficiencies were noted in design plans, requirement procedures, output identification, design reviews, validation, and translation to production specifications. The firm's response regarding compiling historical data for Accuframe® was insufficient without provided data.
2.  **Failure to control design changes (21 CFR 820.30(i))**: A change in titanium specifications (ASTM (b)(4) to ASTM (b)(4)) in 2009 lacked documented rationale, evaluation of effects, and a provided corrective action plan.
3.  **Failure to control process changes (21 CFR 820.70(b))**: Changes to in-process inspection methods by a contract manufacturer, specifically ceasing "DPF" length measurement, lacked documentation, verification

## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/rebecca-asente/0a82a46d-3e13-4a51-8abe-58955bb0095e)
- [Patricia K. Schafer](https://www.keypedia.com/people/patricia-k-schafer/34b879a1-8a40-40f0-a526-e56ac62665e9)

Company: https://www.keypedia.com/companies/cagenix/8228d3e0-3603-4692-bb09-20754f1a7571

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea