FDA 483 - CFS Dental, Inc - September 08, 2022

CFS Dental, Inc. in Hialeah, FL, a medical device manufacturer, was cited for failing to adequately establish and implement design change procedures. Specifically, the firm did not validate current melt times for its CFS Flexible thermoplastic dental resin device across all cartridge sizes. This indicates a breakdown in quality system controls related to product design and manufacturing parameters.