# FDA 483 - AdDent, Inc. - July 24, 2026

Source: https://www.keypedia.com/records/483/addent-inc/acd253e8-53f2-4b78-8a26-27c560743f06

> FDA 483 for AdDent, Inc. on July 24, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AdDent, Inc.
- Inspection Date: 2026-07-24
- Product Type: device
- Office Name: New England District Office
- Summary: AdDent, Inc. in Danbury, CT, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to maintain complete batch records, adequately assess design changes for regulatory impact, and properly manage supplier evaluations, alongside issues with purchased product verification and document control.

## Related Documents

- [483 - 2022-12-08](https://www.keypedia.com/records/483/addent-inc/dbec7495-6cd3-461c-8e31-8962dde8efd8)

## 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/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144