1256855
Augustine Temperature Management, LLC — FEI 3005857264
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 27, 2024
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Minnetonka, MN (United States)
Citations
| ID | CFR | Description |
|---|
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |