640284
Cook Incorporated — FEI 1825146
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 20, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Spencer, IN (United States)
Citations
| ID | CFR | Description |
|---|
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3164 | 21 CFR 820.184(d) | Acceptance records |
| 3288 | 21 CFR 820.90(b)(1) | Documentation of disposition, justification, signature |
| 3386 | 21 CFR 820.25(b)(2) | Training on verification/validation defects |