899086
Xoran Technologies, LLC — FEI 3004198450
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 6, 2014
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ann Arbor, MI (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 5008 | 21 CFR 1002.20(a) | Failure to report |
| 5012 | 21 CFR 1003.10(a) | FDA not notified of defect or noncompliance |
| 5443 | 21 CFR 1020.30(g) | Providing adequate assembly information |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |