AVENTIX ANIMAL HEALTH
⚠️ High Risk
FEI: 3008441059 • Burlington, Ontario • CANADA
FEI Number
3008441059
Location
Burlington, Ontario
Country
CANADAAddress
4350 Mainway, , Burlington, 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
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/18/2025 | 66YPL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northern Border Imports (DNBI) | |
| 7/18/2025 | 66YPR99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 72NEW VET DR | Division of Northern Border Imports (DNBI) |
| 8/22/2020 | 68ZYG99ANIMAL MEDICAL DEVICES, NEC | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 10/23/2009 | 68XYY10SMALL ANIMAL DEVICE/DIAG PROD FOR ANIMAL | 72NEW VET DR | New York District Office (NYK-DO) |
| 10/23/2009 | 68XYY20DEVICE/DIAG PROD FOR ANIMAL USED MORE THAN 1 SPECIES | 72NEW VET DR | New York District Office (NYK-DO) |
Frequently Asked Questions
What is AVENTIX ANIMAL HEALTH's FDA import refusal history?
AVENTIX ANIMAL HEALTH (FEI: 3008441059) has 5 FDA import refusal record(s) in our database, spanning from 10/23/2009 to 7/18/2025.
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. AVENTIX ANIMAL HEALTH's FEI number is 3008441059.
What types of violations has AVENTIX ANIMAL HEALTH received?
AVENTIX ANIMAL HEALTH 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 AVENTIX ANIMAL HEALTH come from?
All FDA import refusal data for AVENTIX ANIMAL HEALTH 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.