FDA 483 - Ultradent Products, Inc. - September 15, 2017

An FDA inspection of Ultradent Products, Inc. in South Jordan, UT, from September 11-15, 2017, revealed a significant facility maintenance issue. The firm failed to maintain buildings used in drug product manufacturing in a good state of repair, specifically noting a jagged hole in a mixing room wall. This condition exposed the wall cavity and loose drywall dust, indicating potential insanitary conditions.