824249
Northern Digital Inc. — FEI 3002743211
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 28, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Waterloo (Canada)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3149 | 21 CFR 820.180 | Availability |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 635 | 21 CFR 803.17(b)(1) | Info evaluated to determine if event was reportable |