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Omrix Biopharmaceuticals Ltd — FDA Facility Profile

FEI 3008640339

Omrix Biopharmaceuticals Ltd is an FDA-registered facility (FEI 3008640339) located in Rehovot, IL. Registered operations: ANALYSIS; API MANUFACTURE; PACK. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection: Mar 5, 2020: Voluntary Action Indicated (VAI)
Inspections on record: 1 (1 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
Form 483 and inspection documents: 1 in FDA's reading room
Recalls as the recalling firm: 1, latest Apr 14, 2016

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

Date	Result	What FDA cited
Mar 5, 2020	Voluntary Action Indicated (VAI)	Following/documenting laboratory controls (21 CFR 211.160(a)) Complete Test Data (21 CFR 211.194(a)(4)) Scientifically sound laboratory controls (21 CFR 211.160(b)) Labeling control records including specimens or copies (21 CFR 211.188(b)(8))

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

Date	Class	Recall	Product and reason
Apr 14, 2016	Class III	B-0131-2017	Fibrin sealant patch Misbranded Fibrin Sealant Patch was distributed.

Form 483s and inspection documents

Mar 5, 2020: 483 on FDA.gov

Facility details

Company: OMRIX Biopharmaceuticals Ltd
Location: Rehovot (IL)
Registration Expires: Dec 31, 2026
Operations: ANALYSIS; API MANUFACTURE; PACK
Source: decrs