# FDA 483 - AdDent, Inc. - December 08, 2022

Source: https://www.keypedia.com/records/483/addent-inc/dbec7495-6cd3-461c-8e31-8962dde8efd8

> FDA 483 for AdDent, Inc. on December 08, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AdDent, Inc.
- Inspection Date: 2022-12-08
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: AdDent, Inc. in Danbury, CT, underwent an FDA inspection from December 6-8, 2022, which identified deficiencies in their finished device acceptance procedures. The firm released Calset Composite Warmers, a Class II device, that either lacked complete temperature testing records or had temperatures outside the specified acceptance range. This indicates a failure in quality control for product release.

## Related Officers

- [Katarzyna Plona](https://www.keypedia.com/people/katarzyna-plona/ea20d6c6-5d2d-41a0-a755-0647fb9f3250)

Company: https://www.keypedia.com/companies/addent-inc/56e0d012-d56a-476c-88ac-d821970f9b29

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