Boehringer Ingelheim Animal Health do Brasil Ltda.
⚠️ High Risk
FEI: 3002764224 • Paulinia, Sao Paulo • BRAZIL
FEI Number
3002764224
Location
Paulinia, Sao Paulo
Country
BRAZILAddress
Avenida Doutor Roberto Moreira, 5005, , Paulinia, Sao Paulo, Brazil
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
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).
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
Frequently Asked Questions
What is Boehringer Ingelheim Animal Health do Brasil Ltda.'s FDA import refusal history?
Boehringer Ingelheim Animal Health do Brasil Ltda. (FEI: 3002764224) has 2 FDA import refusal record(s) in our database, spanning from 8/24/2005 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. Boehringer Ingelheim Animal Health do Brasil Ltda.'s FEI number is 3002764224.
What types of violations has Boehringer Ingelheim Animal Health do Brasil Ltda. received?
Boehringer Ingelheim Animal Health do Brasil Ltda. 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 Boehringer Ingelheim Animal Health do Brasil Ltda. come from?
All FDA import refusal data for Boehringer Ingelheim Animal Health do Brasil Ltda. 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.