Ultradent Products, Inc. – FDA Warning Letter, Nov 8, 2013

On November 4-8, 2013, an FDA inspection of Ultradent Products, Inc. identified significant violations of Current Good Manufacturing Practice (CGMP) and Quality System (QS) regulations (21 CFR Part 820) for their dental devices, specifically the Class II medical device Avex CX/CXi and Avex CX 2 /CXi 2 Orthodontic Ceramic Brackets. The devices were deemed adulterated under section 501(h) of the Act.

Key violations included: 1. **Failure to demonstrate design controls (21 CFR 820.30):** Avex CX 2 /CXi 2 was distributed for clinical use despite being in the feasibility phase, lacking a completed design plan, and using data from partial prototypes for verification. Quality concerns (e.g., debonding, chipping) were noted in full brackets, yet they were re-worked and sent for field testing. Design verification was conducted on unqualified equipment, clinical testing lacked protocols, and manufacturing procedures were not established. The firm's design control procedure was incomplete. Ultradent voluntarily removed the product from the market. 2. **Inadequate corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)):** Recurrent packaging/labeling issues and bonding failures with Avex CX/CXi brackets persisted despite multiple recalls and CAPAs.