1119769
OMRIX Biopharmaceuticals Ltd — FEI 3008640339
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 5, 2020
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Nes-Ziona (Israel)
Citations
| ID | CFR | Description |
|---|
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |