# FDA 483 - Ultradent Products, Inc. - June 13, 2025

Source: https://www.globalkeysolutions.net/records/483/ultradent-products-inc/a610038b-335f-4096-9fea-006239a00b62

> FDA 483 for Ultradent Products, Inc. on June 13, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ultradent Products, Inc.
- Inspection Date: 2025-06-13
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Ultradent Products, Inc. in South Jordan, UT, an OTC human drug manufacturer, was cited for three observations during an FDA inspection. The inspection revealed deficiencies in laboratory controls, including inadequate testing for objectionable microorganisms, and a lack of proper investigation and documentation for unexplained discrepancies and equipment maintenance. Additionally, the firm failed to follow written procedures for equipment cleaning and maintenance, specifically regarding UV lamp intensity and change control for new equipment.

## Related Documents

- [WARNING_LETTER - 2013-11-08](https://www.globalkeysolutions.net/records/warning_letter/ultradent-products-inc/b7b9bccc-0106-4a34-8214-01c437142f8f)
- [483 - 2017-09-15](https://www.globalkeysolutions.net/records/483/ultradent-products-inc/bac4444e-d4c5-4ce4-bd25-14624d8ccdd6)
- [483 - 2020-01-17](https://www.globalkeysolutions.net/records/483/ultradent-products-inc/a637303d-272f-4c64-978e-db982ba91455)

## Related Officers

- [Michael E. Weigman](https://www.globalkeysolutions.net/people/michael-e-weigman/fe9f88f1-7bc4-425e-8757-40c1eef7c939)
- [Michael Z. Weigman](https://www.globalkeysolutions.net/people/michael-z-weigman/fcf79bb1-87cc-476c-a1af-758ef0126ee9)
- [Director of Compliance Branch](https://www.globalkeysolutions.net/people/ronda-r-lloyd-jones/1446ba41-f1f2-4d40-8902-021b2bef3a53)
- [Jeffrey T. Prosterman](https://www.globalkeysolutions.net/people/jeffrey-t-prosterman/1343bea3-692d-484e-b29f-c9f8f052f09c)

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