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Manufacturing facility

Amgen Technology (ireland) Unlimited Company

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 β€” so if this plant has a problem, these are the products that could be affected.

Country
Ireland
Registered address
Pottery Road, Dun Laoghaire, , Ireland (IRL)
Operations here
analysislabelmanufacturepack
FDA identifiers
FEI 3002808497 Β· DUNS 896293920

FDA inspection history

Outcomes of closed FDA inspections at this site (drug and biologic program areas).

  • NAIHuman Cellular, Tissue, and Gene Therapies2023-09-13
  • VAIDrug Quality Assurance2023-07-28
  • VAIDrug Quality Assurance2018-10-26
  • NAIHuman Cellular, Tissue, and Gene Therapies2018-09-20
  • VAIDrug Quality Assurance2017-09-22
  • VAIDrug Quality Assurance2013-03-22
  • VAIDrug Quality Assurance2009-10-29
  • VAIDrug Quality Assurance2009-06-03

Drugs this plant is listed as making

1 distinct drugs across 1 products name this site in their FDA label.

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.

Amgen Technology (ireland) Unlimited Company β€” facility profile Β· DrugDashboards