FDA 483 - Burbank Dental Lab Inc - March 11, 2022

An FDA inspection of Burbank Dental Lab Inc, a Class II medical device contract manufacturer in Burbank, CA, revealed two significant observations. The firm failed to adequately maintain device history records, specifically lacking primary identification labels and labeling. Additionally, the company had not developed written Medical Device Reporting (MDR) procedures, including criteria for adverse events and reporting timeframes.