Boehringer Ingelheim Animal Health USA Inc.
⚠️ High Risk
FEI: 1910185 • Saint Joseph, MO • UNITED STATES
FEI Number
1910185
Location
Saint Joseph, MO
Country
UNITED STATESAddress
2621 N Belt Hwy, , Saint Joseph, MO, 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 | 60ZDA28PONAZURIL (ANTIPARASITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/1/2017 | 66VJE99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/22/2004 | 68YDY02HORSES ANIMAL DRUGS N.E.C. | 72NEW VET DR | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Boehringer Ingelheim Animal Health USA Inc.'s FDA import refusal history?
Boehringer Ingelheim Animal Health USA Inc. (FEI: 1910185) has 3 FDA import refusal record(s) in our database, spanning from 11/22/2004 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. Boehringer Ingelheim Animal Health USA Inc.'s FEI number is 1910185.
What types of violations has Boehringer Ingelheim Animal Health USA Inc. received?
Boehringer Ingelheim Animal Health USA 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 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.