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

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from February 24 to March 4, 2025, Reliance Dental Manufacturing LLC received a Form FDA-483 citing two significant observations related to its quality system for medical devices.The first observation highlighted the company's failure to adequately validate a critical manufacturing process. Specifically, Reliance Dental Manufacturing LLC lacked a written procedure for process validation and subsequently did not validate the blending process for Dura Conditioner Liquid, a critical component for its Class 2 Dura Conditioner device. This device is intended to treat and tone irritated tissue, and numerous packages have been released since January 1, 2024, without this essential validation.The second observation concerned the absence of established procedures for finished device acceptance. The firm’s standard operating procedure (SOP 13) did not specify the required steps for final acceptance prior to the release of finished devices. Consequently, Dura Conditioner devices were distributed without a documented final inspection.These observations indicate a need for Reliance Dental Manufacturing LLC to implement robust quality system controls to ensure product safety and effectiveness. The firm has acknowledged these issues and committed to implementing corrective actions to address the identified deficiencies and comply with regulatory requirements.