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

Source: https://www.keypedia.com/records/483/reliable-s-u-dental-services-inc/2ee2e070-95a7-4979-84f2-b50a2410b32e

> FDA 483 for Reliable S. U. Dental Services, Inc. on December 06, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Reliable S. U. Dental Services, Inc.
- Inspection Date: 2019-12-06
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: 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.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/paul-m-kawamoto/0a24b110-12de-4736-8d98-7a023ceec01e)

Company: https://www.keypedia.com/companies/reliable-s-u-dental-services-inc/2038d001-c527-499b-ad7a-489ef6fbb661

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822