Atlas

FDA-Inspected Site

Amgen Technology (Ireland) Unlimited Company

13 FDA inspections are on record for Amgen Technology (Ireland) Unlimited Company in Dun Laoghaire, Ireland.

483· Form 483 issued

Dun Laoghaire, Ireland · Last updated July 9, 2026

Overview

  • 13 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-09-16.

At a glance

Inspections

13

Form 483s

6

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
8 Sep 2025 – 16 Sep 2025Human Drugs483On file
22 Jul 2024 – 25 Jul 2024Medical Devices & Rad HealthClean
11 Sep 2023 – 13 Sep 2023BiologicsClean
8 Aug 2023 – 16 Aug 2023Human DrugsClean
24 Jul 2023 – 28 Jul 2023Human DrugsClean
18 Sep 2018 – 20 Sep 2018BiologicsClean
14 Sep 2017 – 22 Sep 2017Human Drugs483On file
3 Dec 2015 – 8 Dec 2015Human DrugsClean
25 Mar 2015 – 2 Apr 2015Human Drugs483On file
11 Mar 2013 – 22 Mar 2013Human Drugs483On file
29 Oct 2009Not recorded483On file
3 Jun 2009Not recorded483On file

Investigators

FDA investigators tied to this site in the record.

Charles Cote2 insp.
Wayne E Seifert1 insp.
Stephen D Eich1 insp.
Travis S Bradley1 insp.
Burnell M Henry1 insp.
Laurimer Kuilan-Torres1 insp.
Esther C Broner1 insp.
MRA V MillarW1 insp.
Michele L Forster1 insp.
Shawn E Larson1 insp.
Susan T Hadman1 insp.
Steven Fong1 insp.
Christina A Capacci-Daniel1 insp.
Omotunde O Osunsanmi1 insp.
Michael R Klapal1 insp.
Douglas C Kovacs1 insp.
Neal L Adams1 insp.

Full site report

Get the verbatim findings behind Amgen Technology (Ireland) Unlimited Company's 6 Form 483s

The full inspection record, as Atlas holds it, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat