UCB CANADA
⚠️ High Risk
FEI: 3021507314 • Oakville, Ontario • CANADA
FEI Number
3021507314
Location
Oakville, Ontario
Country
CANADAAddress
2201 Bristol Cir, , Oakville, Ontario, Canada
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 UCB CANADA's FDA import refusal history?
UCB CANADA (FEI: 3021507314) has 2 FDA import refusal record(s) in our database, spanning from 5/10/2024 to 12/22/2025.
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. UCB CANADA's FEI number is 3021507314.
What types of violations has UCB CANADA received?
UCB CANADA 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 UCB CANADA come from?
All FDA import refusal data for UCB CANADA 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.