Amgen Technology (Ireland) Unlimited Company FDA Record
Amgen Technology (Ireland) Unlimited Company has 0 FDA recalls, 9 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Amgen Technology (Ireland) Unlimited Company" is on file.
- Latest inspection
- Jul 25, 2024 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 9 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 2 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 2 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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.
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.
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 25, 2024 | Dun Laoghaire, Ireland | Devices | No Action Indicated (NAI) | 3002808497 |
| Sep 13, 2023 | Dun Laoghaire, Ireland | Biologics | No Action Indicated (NAI) | 3002808497 |
| Jul 28, 2023 | Dun Laoghaire, Ireland | Drugs | Voluntary Action Indicated (VAI) | 3002808497 |
| Oct 26, 2018 | Dun Laoghaire, Ireland | Drugs | Voluntary Action Indicated (VAI) | 3002808497 |
| Sep 20, 2018 | Dun Laoghaire, Ireland | Biologics | No Action Indicated (NAI) | 3002808497 |
| Sep 22, 2017 | Dun Laoghaire, Ireland | Drugs | Voluntary Action Indicated (VAI) | 3002808497 |
| Mar 22, 2013 | Dun Laoghaire, Ireland | Drugs | Voluntary Action Indicated (VAI) | 3002808497 |
| Oct 29, 2009 | Dun Laoghaire, Ireland | Drugs | Voluntary Action Indicated (VAI) | 3002808497 |
| Jun 3, 2009 | Dun Laoghaire, Ireland | Drugs | Voluntary Action Indicated (VAI) | 3002808497 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3002808497 | Dun Laoghaire, Ireland | 9 | Jul 25, 2024 |
Amgen Technology (Ireland) Unlimited Company and the FDA: common questions
Has Amgen Technology (Ireland) Unlimited Company received an FDA warning letter?
No FDA warning letter addressed to the name "Amgen Technology (Ireland) Unlimited Company" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Amgen Technology (Ireland) Unlimited Company received an FDA Form 483?
FDA has not published a Form 483 for "Amgen Technology (Ireland) Unlimited Company" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Amgen Technology (Ireland) Unlimited Company?
The most recent FDA inspection on file ended Jul 25, 2024 at Dun Laoghaire, Ireland and was classified NAI. FDA has 9 inspections of Amgen Technology (Ireland) Unlimited Company on file.
Need more than this page shows? Ask about Amgen Technology (Ireland) Unlimited Company in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.