Astellas Pharma Europe Bv
⚠️ Moderate Risk
FEI: 3005778261 • Leiderdorp, Zuid-Holland • NETHERLANDS
FEI Number
3005778261
Location
Leiderdorp, Zuid-Holland
Country
NETHERLANDSAddress
Elisabethhof 19, , Leiderdorp, Zuid-Holland, Netherlands
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 Astellas Pharma Europe Bv's FDA import refusal history?
Astellas Pharma Europe Bv (FEI: 3005778261) has 1 FDA import refusal record(s) in our database, spanning from 7/3/2012 to 7/3/2012.
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 Bv's FEI number is 3005778261.
What types of violations has Astellas Pharma Europe Bv received?
Astellas Pharma Europe Bv has been cited for 2 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 Bv come from?
All FDA import refusal data for Astellas Pharma 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.