Company
United StatesUltradent Products, Inc., South Jordan, UT – FDA Inspections
Inspection records and compliance data for Ultradent Products, Inc. in South Jordan, Utah. 8 FDA inspections on record (1 OAI), 3 Form 483s, 1 warning letter, last inspected June 13, 2025.
Company Profile
This profile covers Ultradent Products, Inc. based in South Jordan, Utah, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 1
- VAI
- 4
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 1
First inspected January 15, 2010. Last inspected June 13, 2025.
Most cited issue areas
- Scientifically sound laboratory controls2 inspections
- Buildings not maintained in good state of repair1 inspection
- Following/documenting laboratory controls1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 13, 2025 | VAI | Human Drugs · Drug Quality Assurance | 1272589 |
| January 17, 2020 | VAI | Human Drugs · Drug Quality Assurance | 1115289 |
| March 28, 2019 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1086182 |
| September 25, 2018 | Not classified | Medical Devices & Rad Health | 1121811 |
| September 15, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1025250 |
| September 12, 2014 | VAI | Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 895359 |
| November 8, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 854539 |
| January 15, 2010 | NAI | Human Drugs, Medical Devices & Rad Health · Postmarket Assurance: Devices | 644088 |
FDA documents
Warning Letters (1)
Other regulators (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Ultradent Products, Inc.
FEI Number
1718912
Address
505 W 10200 S, South Jordan, Utah 84095, United States
Country
United States
ID: 16b4d8af-54bd-48d3-acc8-a5169bd5bfe3