# FDA 483 - Ultradent Products, Inc. - September 15, 2017

Source: https://www.globalkeysolutions.net/records/483/ultradent-products-inc/bac4444e-d4c5-4ce4-bd25-14624d8ccdd6

> FDA 483 for Ultradent Products, Inc. on September 15, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ultradent Products, Inc.
- Inspection Date: 2017-09-15
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Ultradent Products, Inc. in South Jordan, UT, from September 11-15, 2017, revealed a significant facility maintenance issue. The firm failed to maintain buildings used in drug product manufacturing in a good state of repair, specifically noting a jagged hole in a mixing room wall. This condition exposed the wall cavity and loose drywall dust, indicating potential insanitary conditions.

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## Related Officers

- [Haroon Vohra](https://www.globalkeysolutions.net/people/haroon-vohra/690c60b4-3059-4768-bfca-0cdabc58a72a)

Company: https://www.globalkeysolutions.net/companies/ultradent-products-inc/16b4d8af-54bd-48d3-acc8-a5169bd5bfe3

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face