854539
Ultradent Products, Inc. — FEI 1718912
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 8, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- South Jordan, UT (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14714 | 21 CFR 820.30(c) | Design input - Lack of or inadequate procedures |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3672 | 21 CFR 820.30(c) | Design input - review and approval |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |