Amgen Technology (Ireland) Unlimited Company
⚠️ High Risk
FEI: 3002808497 • Dun Laoghaire, Dublin • IRELAND
FEI Number
3002808497
Location
Dun Laoghaire, Dublin
Country
IRELANDAddress
Pottery Road, , Dun Laoghaire, Dublin, Ireland
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/12/2025 | 58SCY14ADALIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/13/2023 | 62ZCZ35TRASTUZUMAB (ANTI-NEOPLASTIC - PART II) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 7/13/2023 | 62ZCZ35TRASTUZUMAB (ANTI-NEOPLASTIC - PART II) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/29/2018 | 62ICK99ANTI-NEOPLASTIC N.E.C. | Division of Northeast Imports (DNEI) | |
| 3/29/2018 | 62ICK99ANTI-NEOPLASTIC N.E.C. | Division of Northeast Imports (DNEI) | |
| 3/29/2018 | 62ICK99ANTI-NEOPLASTIC N.E.C. | Division of Northeast Imports (DNEI) | |
| 6/17/2007 | 61JDB12LOVASTATIN (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Amgen Technology (Ireland) Unlimited Company's FDA import refusal history?
Amgen Technology (Ireland) Unlimited Company (FEI: 3002808497) has 7 FDA import refusal record(s) in our database, spanning from 6/17/2007 to 8/12/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Amgen Technology (Ireland) Unlimited Company's FEI number is 3002808497.
What types of violations has Amgen Technology (Ireland) Unlimited Company received?
Amgen Technology (Ireland) Unlimited Company has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Amgen Technology (Ireland) Unlimited Company come from?
All FDA import refusal data for Amgen Technology (Ireland) Unlimited Company is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.