657507
James Consolidated, Inc. — FEI 2939266
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 4, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Concord, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2269 | 21 CFR 820.20(a) | Quality policy and objectives |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |