Boehringer Ingelheim Limited
⚠️ Moderate Risk
FEI: 1000237522 • Bracknell, Berkshire • UNITED KINGDOM
FEI Number
1000237522
Location
Bracknell, Berkshire
Country
UNITED KINGDOMAddress
Southern Industrial Estate, Ellesfield Avenue, Bracknell, Berkshire, United Kingdom
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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 |
|---|---|---|---|
| 9/9/2011 | 61KCA99ANTI-CHOLINERGIC, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/9/2011 | 61KAA99ANTI-CHOLINERGIC, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/29/2006 | 66VLA99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 12/14/2005 | 61XCA45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Boehringer Ingelheim Limited's FDA import refusal history?
Boehringer Ingelheim Limited (FEI: 1000237522) has 4 FDA import refusal record(s) in our database, spanning from 12/14/2005 to 9/9/2011.
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 Limited's FEI number is 1000237522.
What types of violations has Boehringer Ingelheim Limited received?
Boehringer Ingelheim Limited 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 Limited come from?
All FDA import refusal data for Boehringer Ingelheim Limited 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.