Boiron Of Canada Inc
⚠️ High Risk
FEI: 3009108624 • Saint-Bruno, Quebec • CANADA
FEI Number
3009108624
Location
Saint-Bruno, Quebec
Country
CANADAAddress
1300 Rene-Descartes St, , Saint-Bruno, Quebec, 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.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
NOCONTACT
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it appears to be a nonprescription drug that is misbranded within the meaning of Section 502(x) of the FD&C Act in that the product label fails to bear a domestic address or phone number through which the responsible person may receive a report of a serious adverse event with such drug.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/5/2025 | 54FFY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/13/2024 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 5/14/2024 | 62UBK99ANTI-TUSSIVE/COLD N.E.C. | Division of Northern Border Imports (DNBI) | |
| 4/29/2024 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 4/29/2024 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 4/15/2024 | 60LBY05ASPIRIN (ANALGESIC) | Division of Northern Border Imports (DNBI) | |
| 1/5/2024 | 61KBK99ANTI-CHOLINERGIC, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 3/15/2023 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/15/2023 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/15/2023 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/15/2023 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/15/2023 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/15/2023 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/25/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/25/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
Frequently Asked Questions
What is Boiron Of Canada Inc's FDA import refusal history?
Boiron Of Canada Inc (FEI: 3009108624) has 44 FDA import refusal record(s) in our database, spanning from 8/25/2011 to 9/5/2025.
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. Boiron Of Canada Inc's FEI number is 3009108624.
What types of violations has Boiron Of Canada Inc received?
Boiron Of Canada Inc 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 Boiron Of Canada Inc come from?
All FDA import refusal data for Boiron Of Canada Inc 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.