558909
Xoran Technologies, LLC — FEI 3004198450
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 4, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Ann Arbor, MI (United States)
Citations
| ID | CFR | Description |
|---|
| 2429 | 21 CFR 820.30(b) | Establish the design and development plan |
| 2602 | 21 CFR 820.30(d) | Design output - review and approval |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 2648 | 21 CFR 820.30(f) | Design verification procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3155 | 21 CFR 820.181(a) | DMR device specifications |
| 3159 | 21 CFR 820.184 | DHR content |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3208 | 21 CFR 820.50(b) | Approval of purchasing data {see also 820.40(a)} |
| 3284 | 21 CFR 820.90(a) | Nonconforming product evaluation/investigation |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3332 | 21 CFR 820.184(e) | ID label, labeling |
| 3419 | 21 CFR 820.70(a)(4) | Approval of process |
| 3673 | 21 CFR 820.30(c) | Design input approval documentation |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 4071 | 21 CFR 820.30(i) | Design changes - validation vs. verification |