1016943
GAMBRO ROSTOCK GMBH — FEI 3007697864
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 6, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Rostock (Germany)
Citations
| ID | CFR | Description |
|---|
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 812 | 21 CFR 803.56 | Submission of Supplement to Individual Report Within One Month |