Univet Pharmaceuticals
⚠️ Moderate Risk
FEI: 3010125311 • Burlington, Ontario • CANADA
FEI Number
3010125311
Location
Burlington, Ontario
Country
CANADAAddress
4087 Harvester Rd Unit 11, , Burlington, Ontario, Canada
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
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.
MFR INSAN
The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
VETDRUGRES
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a new animal drug (or conversion product thereof) that is unsafe within the meaning of Section 512. Product contains
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/13/2011 | 66VMP99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 12/13/2011 | 54ARP13VITAMIN C (ASCORBIC ACID) | 2860VETDRUGRES | New Orleans District Office (NOL-DO) |
| 12/13/2011 | 54ARP05VITAMIN B12 (CYANOCOBALAMIN) | 2860VETDRUGRES | New Orleans District Office (NOL-DO) |
| 10/23/2008 | 60LPL07CAMPHORATED OIL | New York District Office (NYK-DO) | |
| 10/23/2008 | 60SPR99ANTACID, N.E.C. | New York District Office (NYK-DO) | |
| 11/30/2007 | 54AMR99VITAMIN, N.E.C. | 72NEW VET DR | New York District Office (NYK-DO) |
| 11/30/2007 | 54AMR99VITAMIN, N.E.C. | 72NEW VET DR | New York District Office (NYK-DO) |
| 11/30/2007 | 54AMR99VITAMIN, N.E.C. | 72NEW VET DR | New York District Office (NYK-DO) |
| 7/15/2004 | 54AMR99VITAMIN, N.E.C. | 308MFR INSAN | New York District Office (NYK-DO) |
| 7/15/2004 | 54AMR99VITAMIN, N.E.C. | 308MFR INSAN | New York District Office (NYK-DO) |
| 7/15/2004 | 54AMR99VITAMIN, N.E.C. | 308MFR INSAN | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Univet Pharmaceuticals's FDA import refusal history?
Univet Pharmaceuticals (FEI: 3010125311) has 11 FDA import refusal record(s) in our database, spanning from 7/15/2004 to 12/13/2011.
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. Univet Pharmaceuticals's FEI number is 3010125311.
What types of violations has Univet Pharmaceuticals received?
Univet Pharmaceuticals has been cited for 4 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 Univet Pharmaceuticals come from?
All FDA import refusal data for Univet Pharmaceuticals 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.