644088
Ultradent Products, Inc. — FEI 1718912
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- January 15, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- 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 |