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

An FDA inspection of Device Masters Dental Laboratory L.L.C., conducted from November 5-7, 2018, resulted in the issuance of a Form FDA 483. The primary observation highlighted the firm's failure to adequately establish and follow procedures to ensure that all purchased or received products and services conformed to specified requirements. Specifically, investigators found that the company could not demonstrate proper approval and ongoing monitoring of its suppliers and vendors, as mandated by its own "Patient Contact Materials" standard operating procedure. Essential records, such as new vendor verification and supplier performance documentation, were either incomplete or not maintained. Consequently, the FDA was unable to verify that materials and components used in the firm's Class I and II medical devices met the necessary quality standards.This deficiency impacts the quality system for medical device manufacturing, falling under the regulatory oversight of the Federal Food, Drug, and Cosmetic Act. Device Masters Dental Laboratory L.L.C. is required to implement prompt corrective actions to address these findings. This includes establishing and maintaining comprehensive records for all approved suppliers, contractors, and consultants to ensure consistent compliance with quality system requirements. The firm acknowledged the observation and indicated a commitment to rectify the identified issues.