Crystalmark Dental Systems Inc – FDA 483, Oct 22, 2021

An FDA inspection of Crystalmark Dental Systems Inc. in Glendale, CA, a medical device manufacturer, revealed significant deficiencies in their quality system. Observations included inadequate medical device reporting procedures, insufficient training for management, and a lack of established procedures for controlling nonconforming products. These issues indicate a need for comprehensive improvements in their quality management system.