FDA 483 - Reliance Dental Manufacturing LLC - March 04, 2025

Reliance Dental Manufacturing LLC in Alsip, IL, a manufacturer of Class 2 medical devices, was cited with two observations during an FDA inspection. The firm failed to adequately validate its Dura Conditioner Liquid blending process and lacked established procedures for finished device acceptance, leading to the release of uninspected products. These issues indicate significant deficiencies in their quality system regarding process control and product release.