FDA WARNING_LETTER - Cagenix - August 16, 2011

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