FDA 483 - Tristar Dental Laboratory, Inc - July 23, 2019

An FDA inspection of Tristar Dental Laboratory, Inc. in Houston, TX, a specification developer for dental manufacturing, identified two significant observations. The firm failed to establish procedures for receiving, reviewing, and evaluating complaints, and also lacked written Medical Device Reporting (MDR) procedures. These deficiencies indicate a lack of adequate quality system controls for post-market surveillance.