FDA Inspection
Ultradent Products, Inc.Ultradent Products, Inc. – FDA Inspection, Sep 15, 2017
Record Details
This FDA Inspection record concerns Ultradent Products, Inc., with an inspection on September 15, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f53c1f50-8e3a-4190-9346-3baafd7f0a1e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1025250
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.58Buildings not maintained in good state of repair
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Ultradent Products, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| June 13, 2025 | VAI | Denver District Office | Drug Quality Assurance |
| January 17, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 28, 2019 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| September 25, 2018 | Not classified | Denver District Office | |
| September 12, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Ultradent Products, Inc.
- FDA Inspection 1272589 - 2025-06-13
- FDA Inspection 1115289 - 2020-01-17
- FDA Inspection 1086182 - 2019-03-28
- FDA Inspection 1121811 - 2018-09-25
- FDA Inspection 895359 - 2014-09-12
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