Rafa Laboratories Ltd.
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- Israel
- Registered address
- 3 Zeev Lev, Jerusalem, 9777515, Israel (ISR)
- Operations here
- analysislabelmanufacture
- FDA identifiers
- FEI 3004437307 · DUNS 600024855
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2019-11-25
- VAIDrug Quality Assurance2017-11-13
- VAIDrug Quality Assurance2016-09-29
Drugs this plant is listed as making
4 distinct drugs across 4 products name this site in their FDA label.
- Atropine Injection, 2 mgRafa Laboratories, Ltd.
- Atropine Sulfate Injection USP, 0.5 mg/0.7 mLRafa Laboratories, Ltd.
- Atropine Sulfate Injection USP, 1 mg/0.7 mLRafa Laboratories, Ltd.
- Midazolam Injection, 10 mgRafa Laboratories, Ltd.
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.