Boehringer Ingelheim Canada
⚠️ High Risk
FEI: 3001645453 • Burlington, Ontario • CANADA
FEI Number
3001645453
Location
Burlington, Ontario
Country
CANADAAddress
5180 South Service Rd, , Burlington, Ontario, Canada
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/19/2025 | 61PDB73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/12/2025 | 61PCY73EMPAGLIFLOZIN (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 12/8/2025 | 61PCB73EMPAGLIFLOZIN (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 12/1/2025 | 61PDY73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/1/2025 | 61PDB73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/21/2025 | 61PCB73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/14/2025 | 61PCB73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/14/2025 | 61PCB73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/6/2025 | 61PCY73EMPAGLIFLOZIN (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 12/23/2024 | 61PDY73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/23/2024 | 65VOY99SEDATIVE N.E.C. | Division of Southeast Imports (DSEI) | |
| 2/22/2024 | 61PCA73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/29/2023 | 62OCA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/11/2023 | 58ACL02DUPILUMAB | Division of Southeast Imports (DSEI) | |
| 3/11/2022 | 62ODC09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/27/2021 | 64UCB99INHIBITOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/14/2021 | 62JCY15PRAMIPEXOLE (ANTI-PARKINSONIAN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/8/2019 | 61PDB70DAPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/18/2018 | 65VQK99SEDATIVE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/18/2016 | 61LCE41DABIGATRAN ETEXILATE MESYLATE (ANTI-COAGULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/11/2012 | 62OCA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/12/2012 | 62OBA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/21/2011 | 65PCP03TAMSULOSIN HCL (REGULATOR) | Division of Southeast Imports (DSEI) | |
| 10/24/2011 | 66SCB22DIPYRIDAMOLE (VASODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/17/2011 | 64BDA24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/3/2011 | 66RCA01ANGIOTENSIN AMIDE (VASOCONSTRICTOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/21/2009 | 64GDA20FENESTREL (ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/12/2009 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/15/2008 | 63BQL35CLENBUTEROL (BRONCHODILATOR) | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 7/5/2006 | 65PCE03TAMSULOSIN HCL (REGULATOR) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/5/2006 | 65PCA03TAMSULOSIN HCL (REGULATOR) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/26/2006 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/5/2006 | 62JCB15PRAMIPEXOLE (ANTI-PARKINSONIAN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/24/2006 | 62YCA07MELOXICAM (ANTI-INFLAMMATORY, PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/22/2005 | 62CIY99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/27/2004 | 63BCN26IPRATROPIUM BROMIDE (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/17/2004 | 66VQQ99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 1/29/2004 | 63BCQ25FLUTICASONE PROPIONATE (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/21/2003 | 63XAY99DIAGOSTIC AID (DRUGS) N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/12/2002 | 68YYY10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Boehringer Ingelheim Canada's FDA import refusal history?
Boehringer Ingelheim Canada (FEI: 3001645453) has 40 FDA import refusal record(s) in our database, spanning from 3/12/2002 to 12/19/2025.
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 Canada's FEI number is 3001645453.
What types of violations has Boehringer Ingelheim Canada received?
Boehringer Ingelheim Canada 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 Canada come from?
All FDA import refusal data for Boehringer Ingelheim Canada 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.