Biogen Gmbh
⚠️ Moderate Risk
FEI: 3001401009 • Ismaning, Bavaria • GERMANY
FEI Number
3001401009
Location
Ismaning, Bavaria
Country
GERMANYAddress
Carl-Zeiss-Ring 6, , Ismaning, Bavaria, Germany
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
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 Biogen Gmbh's FDA import refusal history?
Biogen Gmbh (FEI: 3001401009) has 2 FDA import refusal record(s) in our database, spanning from 8/19/2011 to 8/19/2011.
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. Biogen Gmbh's FEI number is 3001401009.
What types of violations has Biogen Gmbh received?
Biogen Gmbh 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 Biogen Gmbh come from?
All FDA import refusal data for Biogen Gmbh 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.