# FDA 483 - Viant AS&O Holdings, LLC - October 28, 2024

Source: https://www.keypedia.com/records/483/viant-aso-holdings-llc/36573845-cea1-4c50-b351-8434bf2bd9b7

> FDA 483 for Viant AS&O Holdings, LLC on October 28, 2024. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Viant AS&O Holdings, LLC
- Inspection Date: 2024-10-28
- Product Type: device
- Office Name: New England District Office
- Summary: An FDA inspection of Viant AS&O Holdings, LLC in Brimfield, MA, identified deficiencies in their medical device manufacturing processes. The firm failed to adequately establish procedures for ensuring purchased products and services conform to requirements, including the use of unverified material in Class III medical devices. Additionally, procedures for accepting incoming products were not properly established, with a lack of documented equipment verification checks and outdated procedures.

## Related Officers

- [Power Trader/Data Scientist](https://www.keypedia.com/people/jeffrey-j-thibodeau/62b74030-4aef-400b-8ae2-8bf84712d813)

Company: https://www.keypedia.com/companies/viant-aso-holdings-llc/d19ee33d-33f5-4144-b405-adb9563b6a46

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144