695219
Xoran Technologies, LLC — FEI 3004198450
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 14, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ann Arbor, MI (United States)
Citations
| ID | CFR | Description |
|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 5012 | 21 CFR 1003.10(a) | FDA not notified of defect or noncompliance |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |