FDA 483 - Dental Technologies Inc. - February 10, 2026

Dental Technologies, Inc. in Lincolnwood, IL, a manufacturer, was inspected from February 3-10, 2026, and received four observations related to significant quality system deficiencies. The inspection revealed issues with inadequate batch failure investigations, a non-compliant quality control unit, failures in labeling material control, and a lack of established cleaning and maintenance procedures for equipment, including repeat observations from prior inspections. These findings indicate systemic problems in ensuring product quality and regulatory compliance.