FDA 483 - Ultradent Products, Inc. - January 17, 2020

Ultradent Products, Inc., an OTC drug manufacturer in South Jordan, UT, was cited for three observations during an FDA inspection. The firm failed to establish accuracy and reproducibility of test methods, lacked scientifically sound specifications for drug products, and did not ensure proper documentation and secondary review of laboratory records. These issues indicate deficiencies in their laboratory controls and quality assurance processes.