Virbac Australia Ltd Pty
⚠️ High Risk
FEI: 3006984237 • Milperra, New South Wales • AUSTRALIA
FEI Number
3006984237
Location
Milperra, New South Wales
Country
AUSTRALIAAddress
361 Horsley Road, , Milperra, New South Wales, Australia
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.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/25/2014 | 68IBL20TONIC USED MORE THAN 1 SPECIES | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 7/23/2014 | 68YYY99OTHER ANIMAL, N.E.C. ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 7/11/2014 | 68YYY99OTHER ANIMAL, N.E.C. ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 7/11/2014 | 68YYY99OTHER ANIMAL, N.E.C. ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 6/23/2014 | 68YYL99OTHER ANIMAL, N.E.C. ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 6/6/2014 | 68YYY99OTHER ANIMAL, N.E.C. ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 6/4/2014 | 68YYY99OTHER ANIMAL, N.E.C. ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 5/21/2014 | 68FCK99OTHER ANIMAL, N.E.C. HORMONES | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 5/12/2014 | 68YYY99OTHER ANIMAL, N.E.C. ANIMAL DRUGS N.E.C. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Virbac Australia Ltd Pty's FDA import refusal history?
Virbac Australia Ltd Pty (FEI: 3006984237) has 9 FDA import refusal record(s) in our database, spanning from 5/12/2014 to 8/25/2014.
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. Virbac Australia Ltd Pty's FEI number is 3006984237.
What types of violations has Virbac Australia Ltd Pty received?
Virbac Australia Ltd Pty 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 Virbac Australia Ltd Pty come from?
All FDA import refusal data for Virbac Australia Ltd Pty 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.