# FDA 483 - Vivos Therapeutics Inc. - October 24, 2024

Source: https://www.globalkeysolutions.net/records/483/vivos-therapeutics-inc/afdab258-3d39-4c27-a4b2-4824737b503c

> FDA 483 for Vivos Therapeutics Inc. on October 24, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vivos Therapeutics Inc.
- Inspection Date: 2024-10-24
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Vivos Therapeutics Inc. in Murray, KY, revealed deficiencies in their complaint handling procedures. The firm's complaint records were found to inconsistently include required device identification (UDI/UPC) and lacked adequate documentation to support root cause determinations. These issues indicate a need for improvement in their quality system for managing complaints.

## Related Documents

- [483 - 2022-10-28](https://www.globalkeysolutions.net/records/483/vivos-therapeutics-inc/28fae599-d5ea-45d4-a8db-ffa775d05621)

## 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