1162460
InfuTronix LLC — FEI 3011581906
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 15, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Natick, MA (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |