1276533
ATZ Manufacturing — FEI 3014653196
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 24, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Marshall, MN (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 537 | 21 CFR 820.70(a) | Production processes |