Boehringer Ingelheim (Canada) Ltd
⚠️ Moderate Risk
FEI: 3001584190 • Laval, Quebec • CANADA
FEI Number
3001584190
Location
Laval, Quebec
Country
CANADAAddress
2100 Cunard St, , Laval, Quebec, Canada
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).
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 |
|---|---|---|---|
| 2/5/2007 | 77KCOINHALER, NASAL | Detroit District Office (DET-DO) | |
| 2/5/2007 | 66SCY99VASODILATOR N.E.C. | Detroit District Office (DET-DO) | |
| 7/5/2006 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Boehringer Ingelheim (Canada) Ltd's FDA import refusal history?
Boehringer Ingelheim (Canada) Ltd (FEI: 3001584190) has 3 FDA import refusal record(s) in our database, spanning from 7/5/2006 to 2/5/2007.
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) Ltd's FEI number is 3001584190.
What types of violations has Boehringer Ingelheim (Canada) Ltd received?
Boehringer Ingelheim (Canada) Ltd has been cited for 4 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) Ltd come from?
All FDA import refusal data for Boehringer Ingelheim (Canada) Ltd 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.