Intervet International, BV
⚠️ High Risk
FEI: 3002807287 • Boxmeer, Noord-Brabant • NETHERLANDS
FEI Number
3002807287
Location
Boxmeer, Noord-Brabant
Country
NETHERLANDSAddress
Wim de Korverstraat 35, , Boxmeer, Noord-Brabant, Netherlands
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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/12/2023 | 60ZDY13FLURALANER (ANTIPARASITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/24/2017 | 68YYY99OTHER ANIMAL, N.E.C. ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 7/20/2016 | 55YY99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 8/31/2005 | 68YAK20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Intervet International, BV's FDA import refusal history?
Intervet International, BV (FEI: 3002807287) has 4 FDA import refusal record(s) in our database, spanning from 8/31/2005 to 10/12/2023.
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. Intervet International, BV's FEI number is 3002807287.
What types of violations has Intervet International, BV received?
Intervet International, BV 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 Intervet International, BV come from?
All FDA import refusal data for Intervet International, BV 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.