668494
Augustine Temperature Management, LLC — FEI 3005857264
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 14, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Minnetonka, MN (United States)
Citations
| ID | CFR | Description |
|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |
| 3696 | 21 CFR 820.100(b) | Documentation |