# FDA 483 - Medmix US Inc. - December 06, 2022

Source: https://www.keypedia.com/records/483/medmix-us-inc/1e7c5462-a957-4e11-9843-77828b0a7452

> FDA 483 for Medmix US Inc. on December 06, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medmix US Inc.
- Inspection Date: 2022-12-06
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Medmix US Inc. in Salem, NH, conducted from December 5-6, 2022, identified one significant observation. The firm failed to document the evaluation of a supplier providing finished dental devices, including the Advance Injection Needle, which they have been importing and selling since 2018. This indicates a lapse in their quality system regarding supplier control.

## Related Officers

- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.keypedia.com/companies/medmix-us-inc/92528046-d1ec-4e1c-816d-114cb805a612

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94