FDA 483 - Dental Technologies, Inc.

Dental Technologies, Inc. in Lincolnwood, IL, a drug manufacturer, was inspected by the FDA from December 2020 to January 2021. The inspection revealed significant deficiencies across its quality control unit, investigations, microbiological testing, water system, cleaning procedures, and documentation. These issues indicate a systemic failure to ensure drug product quality and prevent contamination, particularly with objectionable microorganisms like Burkholderia cepacia and Pseudomonas aeruginosa.