# FDA 483 - Vivos Therapeutics Inc. - October 28, 2022

Source: https://www.globalkeysolutions.net/records/483/vivos-therapeutics-inc/28fae599-d5ea-45d4-a8db-ffa775d05621

> FDA 483 for Vivos Therapeutics Inc. on October 28, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vivos Therapeutics Inc.
- Inspection Date: 2022-10-28
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Vivos Therapeutics Inc. in Murray, KY, revealed significant deficiencies in the firm's quality system. Observations included inadequate procedures for design changes, poorly maintained complaint files, and inconsistent documentation of corrective and preventive actions. These issues indicate a need for improved adherence to regulatory requirements for medical device manufacturing.

## Related Documents

- [483 - 2024-10-24](https://www.globalkeysolutions.net/records/483/vivos-therapeutics-inc/afdab258-3d39-4c27-a4b2-4824737b503c)

## Related Officers

- [Shannon A. Gregory](https://www.globalkeysolutions.net/people/shannon-a-gregory/3e791321-dced-4e1d-89a1-3da91d577961)

Company: https://www.globalkeysolutions.net/companies/vivos-therapeutics-inc/eb31dac7-ec9b-4e68-b9c6-ddd7c58d60da

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22