Astellas Ireland Co., 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
- Bansha, Killorglin, Co Kerry V93FC86, Ireland (IRL)
- Operations here
- analysismanufacturepack
- FDA identifiers
- FEI 3002807020 · DUNS 985098269
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2022-09-02
- VAIDrug Quality Assurance2019-11-08
- NAIDrug Quality Assurance2017-05-23
- NAIDrug Quality Assurance2014-11-21
- VAIDrug Quality Assurance2013-03-08
Drugs this plant is listed as making
1 distinct drugs across 3 products name this site in their FDA label.
- tacrolimus extended-release capsulesAstellas Pharma US, Inc.
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.