Astellas Pharma Europe B.V.
⚠️ High Risk
FEI: 3010489867 • Leiden • NETHERLANDS
FEI Number
3010489867
Location
Leiden
Country
NETHERLANDSAddress
Sylviusweg 62, , Leiden, , 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
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/3/2025 | 61BDY05FLUTAMIDE (ANTI-ANDROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/12/2017 | 66YDY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/18/2017 | 61FDJ33ERTHROMYCIN ETHYLCARBONATE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 2/10/2014 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Astellas Pharma Europe B.V.'s FDA import refusal history?
Astellas Pharma Europe B.V. (FEI: 3010489867) has 4 FDA import refusal record(s) in our database, spanning from 2/10/2014 to 7/3/2025.
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. Astellas Pharma Europe B.V.'s FEI number is 3010489867.
What types of violations has Astellas Pharma Europe B.V. received?
Astellas Pharma Europe B.V. 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 Astellas Pharma Europe B.V. come from?
All FDA import refusal data for Astellas Pharma Europe B.V. 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.