# FDA 483 - Vivos Therapeutics, Inc. - August 27, 2020

Source: https://www.globalkeysolutions.net/records/483/vivos-therapeutics-inc/434f0091-2a1f-4abb-a0f8-2a77590f91f3

> FDA 483 for Vivos Therapeutics, Inc. on August 27, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vivos Therapeutics, Inc.
- Inspection Date: 2020-08-27
- Product Type: device
- Office Name: Denver District Office
- Summary: Vivos Therapeutics, Inc. in Highlands Ranch, CO, a medical device manufacturer, was cited for significant deficiencies during an FDA inspection. The firm's design history file for its Vivos mRNA appliance® lacked required documentation and components, failing to demonstrate proper design control. Additionally, procedures for corrective and preventive actions (CAPA) were inadequately established and documented, leading to objectionable conditions in reviewed CAPA records.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/matthew-m-vernon/f77e8c18-8614-49e3-9b19-3327b7fe7648)

Company: https://www.globalkeysolutions.net/companies/vivos-therapeutics-inc/1caa9650-0b6e-4db3-88b2-79cfd180b012

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