1214802
Fresenius Medical Care Holdings, Inc. — FEI 3001451489
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 2, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Waltham, MA (United States)
Citations
| ID | CFR | Description |
|---|
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |