FDA Inspection 644088 — Ultradent Products, Inc.
The FDA completed an inspection of Ultradent Products, Inc. on Jan 15, 2010 in South Jordan, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 15, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- South Jordan, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3167 | 21 CFR 820.198(a) | Complete files maintained |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |