FDA 483 - Device Masters Dental Laboratory L.L.C. - November 07, 2018

An FDA inspection of Device Masters Dental Laboratory L.L.C. in Williamsburg, MI, a medical device establishment, revealed a significant issue with their supplier management. The firm failed to adequately establish procedures to ensure purchased products and services conform to specified requirements, specifically regarding the approval and monitoring of suppliers. This indicates a moderate severity issue related to quality system controls for medical devices.