OMRIX BIOPHARMACEUTICALS LTD — FDA Facility Profile
OMRIX BIOPHARMACEUTICALS LTD is an FDA-registered facility (FEI 3003183625) located in RAMAT GAN, IL. Registered operations: ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK. RegDataLab tracks 3 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Feb 24, 2020: Voluntary Action Indicated (VAI)
- Inspections on record
- 3 (3 VAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 1, latest Jul 8, 2019
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Feb 24, 2020 | Voluntary Action Indicated (VAI) | No citations listed |
| Nov 5, 2012 | Voluntary Action Indicated (VAI) | No citations listed |
| Oct 29, 2009 | Voluntary Action Indicated (VAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jul 8, 2019 | Not yet classified | B-0869-2019 | Fibrin Sealant EVICEL Fibrin Sealant 5mL Sample, (Not for Sale) and not meeting product specifications, was distributed. |
Facility details
- Company
- OMRIX Biopharmaceuticals Ltd.
- Location
- RAMAT GAN (IL)
- Registration Expires
- Dec 31, 2027
- Operations
- ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK
- Source
- decrs