# FDA 483 - ASD Sleep, LLC dba American Sleep Dentistry - September 09, 2022

Source: https://www.globalkeysolutions.net/records/483/asd-sleep-llc-dba-american-sleep-dentistry/8573f3c8-ff08-4914-b406-86fbd74ef753

> FDA 483 for ASD Sleep, LLC dba American Sleep Dentistry on September 09, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ASD Sleep, LLC dba American Sleep Dentistry
- Inspection Date: 2022-09-09
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of ASD Sleep, LLC dba American Sleep Dentistry in Cedar City, UT, a medical device manufacturer, revealed significant deficiencies in their quality management system. The firm failed to adequately establish procedures for controlling nonconforming products and design changes, and did not properly maintain device history and master records. Additionally, labeling was not sufficiently examined, and Unique Device Identifier (UDI) implementation was lacking.

## Related Officers

- [James R. Montero](https://www.globalkeysolutions.net/people/james-r-montero/ce2d19fd-25b7-423e-9132-5d6f582380d2)

Company: https://www.globalkeysolutions.net/companies/asd-sleep-llc-dba-american-sleep-dentistry/c4c8df9a-4dd7-4dad-b88d-65cce6a28f59

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face