LEO 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
- Ireland
- Registered address
- 285 Cashel Road, Crumlin, Dublin, Dublin 12, Ireland (IRL)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3002807468 · DUNS 219532322
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2022-06-24
- NAIDrug Quality Assurance2017-11-03
- NAIDrug Quality Assurance2014-03-14
- NAIDrug Quality Assurance2011-09-09
- VAIDrug Quality Assurance2008-12-08
Drugs this plant is listed as making
5 distinct drugs across 7 products name this site in their FDA label.
- calcipotrienePrasco Laboratories
- calcipotriene and betamethasone dipropionateLEO Pharma Inc.
- TacrolimusPadagis Israel Pharmaceuticals 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.