Dental Technologies Inc. – FDA 483, Feb 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.
ID · 25fec9ae-f45b-4805-aa9a-65bfb855f748
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