Zoetis LLC
⚠️ High Risk
FEI: 3010146372 • Kalamazoo, MI • UNITED STATES
FEI Number
3010146372
Location
Kalamazoo, MI
Country
UNITED STATESAddress
2605 E Kilgore Rd, , Kalamazoo, MI, 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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 |
|---|---|---|---|
| 10/10/2025 | 60ZPL35SELAMECTIN (ANTIPARASITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/10/2025 | 60ZPL35SELAMECTIN (ANTIPARASITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/10/2025 | 60ZOK35SELAMECTIN (ANTIPARASITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/3/2025 | 60ZDY34SAROLANER (ANTIPARASITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/26/2015 | 56YJN99ANTIBIOTIC N.E.C. | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 2/26/2015 | 56YJP99ANTIBIOTIC N.E.C. | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 2/26/2015 | 56YJP99ANTIBIOTIC N.E.C. | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 2/26/2015 | 56YJN99ANTIBIOTIC N.E.C. | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 2/26/2015 | 56YJN99ANTIBIOTIC N.E.C. | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Zoetis LLC's FDA import refusal history?
Zoetis LLC (FEI: 3010146372) has 9 FDA import refusal record(s) in our database, spanning from 2/26/2015 to 10/10/2025.
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 LLC's FEI number is 3010146372.
What types of violations has Zoetis LLC received?
Zoetis LLC 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 Zoetis LLC come from?
All FDA import refusal data for Zoetis LLC 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.