FDA 483 - Reliable S. U. Dental Services, Inc. - December 06, 2019

Reliable S. U. Dental Services, Inc. in Lynnwood, WA, an initial importer and repackager of dental devices, was cited for significant deficiencies in its quality system. The inspection revealed a lack of established procedures for Medical Device Reporting, complaint handling, control of nonconforming product, and corrective and preventive actions. These issues indicate a fundamental failure to implement essential quality system requirements for medical device firms.