FDA Inspection 1119769 — OMRIX Biopharmaceuticals Ltd
The FDA completed an inspection of OMRIX Biopharmaceuticals Ltd on Mar 5, 2020 in Nes-Ziona. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 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 |