FDA 483 - Ultradent Products, Inc. - June 13, 2025

Ultradent Products, Inc. in South Jordan, UT, an OTC human drug manufacturer, was cited for three observations during an FDA inspection. The inspection revealed deficiencies in laboratory controls, including inadequate testing for objectionable microorganisms, and a lack of proper investigation and documentation for unexplained discrepancies and equipment maintenance. Additionally, the firm failed to follow written procedures for equipment cleaning and maintenance, specifically regarding UV lamp intensity and change control for new equipment.