Amgen Europe BV
⚠️ High Risk
FEI: 3005889661 • Breda, Noord-Brabant • NETHERLANDS
FEI Number
3005889661
Location
Breda, Noord-Brabant
Country
NETHERLANDSAddress
Minervum 7061, Postbus 3345, Breda, Noord-Brabant, Netherlands
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).
Refusal History
Frequently Asked Questions
What is Amgen Europe BV's FDA import refusal history?
Amgen Europe BV (FEI: 3005889661) has 2 FDA import refusal record(s) in our database, spanning from 7/2/2020 to 9/3/2025.
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 Europe BV's FEI number is 3005889661.
What types of violations has Amgen Europe BV received?
Amgen Europe BV has been cited for 1 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 Europe BV come from?
All FDA import refusal data for Amgen Europe BV 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.