Boehringer Ingelheim Animal Health USA Inc
⚠️ High Risk
FEI: 3003809686 • Duluth, GA • UNITED STATES
FEI Number
3003809686
Location
Duluth, GA
Country
UNITED STATESAddress
3239 Satellite Blvd, , Duluth, GA, 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
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 |
|---|---|---|---|
| 3/1/2017 | 68YCA10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 2/21/2017 | 68YCA10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 2/21/2017 | 62LPA47IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 2/21/2017 | 62LPA47IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 2/15/2017 | 68YYA99OTHER ANIMAL, N.E.C. ANIMAL DRUGS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 2/14/2017 | 62LPA47IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 2/9/2017 | 62LPA47IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 2/9/2017 | 60WRA31PYRANTEL PAMOATE (ANTHELMINTIC) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 2/3/2017 | 62LBA47IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Boehringer Ingelheim Animal Health USA Inc's FDA import refusal history?
Boehringer Ingelheim Animal Health USA Inc (FEI: 3003809686) has 9 FDA import refusal record(s) in our database, spanning from 2/3/2017 to 3/1/2017.
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. Boehringer Ingelheim Animal Health USA Inc's FEI number is 3003809686.
What types of violations has Boehringer Ingelheim Animal Health USA Inc received?
Boehringer Ingelheim Animal Health USA Inc has been cited for 1 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 Boehringer Ingelheim Animal Health USA Inc come from?
All FDA import refusal data for Boehringer Ingelheim Animal Health USA 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.