Virbac AH, Inc
⚠️ High Risk
FEI: 1628888 • Westlake, TX • UNITED STATES
FEI Number
1628888
Location
Westlake, TX
Country
UNITED STATESAddress
1301 Solana Blvd Ste 2400, , Westlake, TX, United States
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/16/2024 | 56GCA99ANTIFUNGAL N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/16/2024 | 56YCL99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/26/2005 | 62VOK31INTERFERON ALFA-2B, RECOMBINANT/RIBAVIRI (ANTI-VIRAL) | 72NEW VET DR | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Virbac AH, Inc's FDA import refusal history?
Virbac AH, Inc (FEI: 1628888) has 3 FDA import refusal record(s) in our database, spanning from 1/26/2005 to 1/16/2024.
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 AH, Inc's FEI number is 1628888.
What types of violations has Virbac AH, Inc received?
Virbac AH, Inc 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 AH, Inc come from?
All FDA import refusal data for Virbac AH, Inc 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.