FDA 483 - Dentonics, Inc - April 28, 2022

Dentonics, Inc. in Monroe, NC, was inspected from April 20-28, 2022, and received nine observations related to significant deficiencies in their quality system. Key issues include a lack of process validation for Glass Ionomer Luting Cement, inadequate purchasing controls for suppliers and consultants, and failures in maintaining device master records, labeling procedures, equipment calibration, and document and distribution controls. These findings indicate a broad lack of adherence to established procedures and regulatory requirements for medical device manufacturing.