Zoetis Belgium S.A.
⚠️ High Risk
FEI: 3010087842 • Louvain-la-Neuve, Brabant wallon • BELGIUM
FEI Number
3010087842
Location
Louvain-la-Neuve, Brabant wallon
Country
BELGIUMAddress
Rue Laid Burniat 1/1348, , Louvain-la-Neuve, Brabant wallon, Belgium
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).
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 |
|---|---|---|---|
| 12/10/2025 | 60ZOA34SAROLANER (ANTIPARASITIC) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 12/10/2025 | 60ZRA32PYRANTEL PAMOATE (ANTIPARASITIC) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 10/10/2025 | 60ZOA34SAROLANER (ANTIPARASITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/23/2017 | 68YYY99OTHER ANIMAL, N.E.C. ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 7/29/2016 | 68YCA10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 2/17/2007 | 65KCK08LATANOPROST (PROSTAGLANDIN) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Zoetis Belgium S.A.'s FDA import refusal history?
Zoetis Belgium S.A. (FEI: 3010087842) has 6 FDA import refusal record(s) in our database, spanning from 2/17/2007 to 12/10/2025.
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. Zoetis Belgium S.A.'s FEI number is 3010087842.
What types of violations has Zoetis Belgium S.A. received?
Zoetis Belgium S.A. has been cited for 3 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 Zoetis Belgium S.A. come from?
All FDA import refusal data for Zoetis Belgium S.A. 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.