817769
Fresenius Medical Care Holdings, Inc. — FEI 3001451489
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 21, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Waltham, 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 |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |