Omrix Biopharmaceuticals , Ltd.
Omrix Biopharmaceuticals , Ltd. has 0 FDA recalls, 4 inspections, 3 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Mar 5, 2020 · VAI
- Latest 510(k)
- Feb 20, 2009
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 3 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 4 | Nov 13, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 5, 2020 | Nes-Ziona, Israel | Biologics | Voluntary Action Indicated (VAI) | 3008640339 |
| Feb 24, 2020 | Ramat Gan, Israel | Biologics | Voluntary Action Indicated (VAI) | 3003183625 |
| Nov 5, 2012 | Ramat Gan, Israel | Biologics | Voluntary Action Indicated (VAI) | 3003183625 |
| Oct 29, 2009 | Ramat Gan, Israel | Biologics | Voluntary Action Indicated (VAI) | 3003183625 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3008640339 | Nes-Ziona, Israel | 1 | Mar 5, 2020 |
| FEI 3003183625 | Ramat Gan, Israel | 3 | Feb 24, 2020 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K090162 | EVICEL APPLICATION DEVICE | Feb 20, 2009 |
| K070575 | EVICEL APPLICATION DEVICE | May 29, 2007 |
| K030032 | CROSSEAL APPLICATION DEVICE | Mar 21, 2003 |
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