FDA 483 - Medmix US Inc. - December 06, 2022

An FDA inspection of Medmix US Inc. in Salem, NH, conducted from December 5-6, 2022, identified one significant observation. The firm failed to document the evaluation of a supplier providing finished dental devices, including the Advance Injection Needle, which they have been importing and selling since 2018. This indicates a lapse in their quality system regarding supplier control.