779682
Xoran Technologies, LLC — FEI 3004198450
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 14, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ann Arbor, MI (United States)
Citations
| ID | CFR | Description |
|---|
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3147 | 21 CFR 820.170(a) | Lack of or inadequate instructions |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3837 | 21 CFR 820.25(b) | Training records |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 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 |
| 5013 | 21 CFR 1003.10(b) | Dealers, distributors, purchasers not notified |
| 5019 | 21 CFR 1004.1 | CAP not submitted |
| 5034 | 21 CFR 1010.2(c) | Certification not based on adequate test/testing program |
| 537 | 21 CFR 820.70(a) | Production processes |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |