483
CFS Dental, IncCFS Dental, Inc – FDA 483, Sep 8, 2022
Record Details
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.
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ID · 5beae3a2-dc9f-4795-a72d-5a43d19e6c55
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