Boehringer Ingelheim Pharma Gmbh & Co Kg
⚠️ High Risk
FEI: 3002806518 • Biberach An Der Ris, Baden-Wurttemberg • GERMANY
FEI Number
3002806518
Location
Biberach An Der Ris, Baden-Wurttemberg
Country
GERMANYAddress
Boehringer Ingelheim Pharma Gmbh & Co. Kg, Birkendorfer Str. 65, Biberach An Der Ris, Baden-Wurttemberg, Germany
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).
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).
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
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 |
|---|---|---|---|
| 11/21/2025 | 58MCK06INTERFERON BETA-1B | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/26/2022 | 61PCA26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 5/26/2022 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/24/2022 | 62ZIS19ALDESLEUKIN (ANTI-NEOPLASTIC - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/9/2020 | 62YQK07MELOXICAM (ANTI-INFLAMMATORY, PART II) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 5/12/2020 | 62OCB09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 342PERSONALRX | Division of Southeast Imports (DSEI) |
| 8/1/2014 | 57YL99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | New York District Office (NYK-DO) |
| 3/22/2013 | 61KBY27HYOSCYAMINE SULFATE (ANTI-CHOLINERGIC) | New Orleans District Office (NOL-DO) | |
| 3/22/2013 | 61KBY27HYOSCYAMINE SULFATE (ANTI-CHOLINERGIC) | New Orleans District Office (NOL-DO) | |
| 8/29/2006 | 77KAKPROBE, ENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/29/2006 | 73JFEVALVE, SWITCHING (PLOSS) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/29/2006 | 73BTSTUBE, BRONCHIAL (W/WO CONNECTOR) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/29/2006 | 80FMFSYRINGE, PISTON | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 7/26/2006 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/18/2003 | 62UAL99ANTI-TUSSIVE/COLD N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/14/2003 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/29/2002 | 60CCS09PHENYLEPHRINE HCL (ADRENERGIC) | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Boehringer Ingelheim Pharma Gmbh & Co Kg's FDA import refusal history?
Boehringer Ingelheim Pharma Gmbh & Co Kg (FEI: 3002806518) has 17 FDA import refusal record(s) in our database, spanning from 7/29/2002 to 11/21/2025.
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 Pharma Gmbh & Co Kg's FEI number is 3002806518.
What types of violations has Boehringer Ingelheim Pharma Gmbh & Co Kg received?
Boehringer Ingelheim Pharma Gmbh & Co Kg has been cited for 5 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 Pharma Gmbh & Co Kg come from?
All FDA import refusal data for Boehringer Ingelheim Pharma Gmbh & Co Kg 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.