Amgen Technology (Ireland) Unlimited Company — FDA Facility Profile

FEI 3002808497

Amgen Technology (Ireland) Unlimited Company is an FDA-registered facility (FEI 3002808497) located in Dun Laoghaire, IE. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 9 FDA inspections at this facility.

Reviewing Amgen Technology (Ireland) Unlimited Company as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Amgen Technology (Ireland) Unlimited Company yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

What FDA found at this site

Latest inspection
Jul 25, 2024: No Action Indicated (NAI)
Inspections on record
9 (6 VAI, 3 NAI)
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
Import refusals
7

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.

DateResultWhat FDA cited
Jul 25, 2024No Action Indicated (NAI)No citations listed
Sep 13, 2023No Action Indicated (NAI)No citations listed
Jul 28, 2023Voluntary Action Indicated (VAI)No citations listed
Oct 26, 2018Voluntary Action Indicated (VAI)No citations listed
Sep 20, 2018No Action Indicated (NAI)No citations listed
Sep 22, 2017Voluntary Action Indicated (VAI)No citations listed
Mar 22, 2013Voluntary Action Indicated (VAI)No citations listed
Oct 29, 2009Voluntary Action Indicated (VAI)No citations listed
Jun 3, 2009Voluntary Action Indicated (VAI)No citations listed

Facility details

Company
Amgen Technology (Ireland) Unlimited Company
Location
Dun Laoghaire (IE)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
decrs

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.