1278050
Fresenius Kabi USA, LLC — FEI 3014732157
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 8, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- North Andover, MA (United States)
Citations
| ID | CFR | Description |
|---|
| 14714 | 21 CFR 820.30(c) | Design input - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate 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 |