Labomar Canada Inc
⚠️ High Risk
FEI: 3000999767 • Pointe-Claire, Quebec • CANADA
FEI Number
3000999767
Location
Pointe-Claire, Quebec
Country
CANADAAddress
50 Hymus Blvd, , Pointe-Claire, 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).
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 |
|---|---|---|---|
| 8/11/2025 | 53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/22/2025 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/22/2025 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/16/2025 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/3/2025 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/3/2025 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/19/2025 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/6/2025 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/6/2025 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/20/2021 | 63VAL02HYDROQUINONE (DEPIGMENTOR) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 12/5/2014 | 63VCJ02HYDROQUINONE (DEPIGMENTOR) | New York District Office (NYK-DO) | |
| 12/5/2014 | 63VCJ02HYDROQUINONE (DEPIGMENTOR) | New York District Office (NYK-DO) | |
| 12/5/2014 | 63VCL02HYDROQUINONE (DEPIGMENTOR) | New York District Office (NYK-DO) | |
| 9/11/2014 | 53LC07NIGHT (SKIN CARE PREPARATIONS) | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/18/2013 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 3/18/2013 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 3/18/2013 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 2/25/2013 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | New England District Office (NWE-DO) | |
| 2/19/2013 | 63VBL99DEPIGMENTOR N.E.C. | New York District Office (NYK-DO) | |
| 2/19/2013 | 63VCJ02HYDROQUINONE (DEPIGMENTOR) | New York District Office (NYK-DO) | |
| 2/19/2013 | 63VBL99DEPIGMENTOR N.E.C. | New York District Office (NYK-DO) | |
| 2/19/2013 | 63VCJ02HYDROQUINONE (DEPIGMENTOR) | New York District Office (NYK-DO) | |
| 2/19/2013 | 63VCJ02HYDROQUINONE (DEPIGMENTOR) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 2/19/2013 | 63VCJ02HYDROQUINONE (DEPIGMENTOR) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/18/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Detroit District Office (DET-DO) |
| 12/18/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Detroit District Office (DET-DO) |
| 10/9/2012 | 62ODL49NIMODIPINE (ANTI-HYPERTENSIVE - PART II) | New York District Office (NYK-DO) | |
| 9/14/2012 | 63VBL99DEPIGMENTOR N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/14/2012 | 63VCJ02HYDROQUINONE (DEPIGMENTOR) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/14/2012 | 63VCJ02HYDROQUINONE (DEPIGMENTOR) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/8/2012 | 63VCJ02HYDROQUINONE (DEPIGMENTOR) | New York District Office (NYK-DO) | |
| 8/8/2012 | 63VCJ02HYDROQUINONE (DEPIGMENTOR) | New York District Office (NYK-DO) | |
| 8/8/2012 | 63VBL99DEPIGMENTOR N.E.C. | New York District Office (NYK-DO) | |
| 8/8/2012 | 63VBL99DEPIGMENTOR N.E.C. | New York District Office (NYK-DO) | |
| 8/8/2012 | 63VCJ02HYDROQUINONE (DEPIGMENTOR) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/8/2012 | 63VCJ02HYDROQUINONE (DEPIGMENTOR) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/13/2010 | 63VDL02HYDROQUINONE (DEPIGMENTOR) | New York District Office (NYK-DO) | |
| 1/13/2010 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 7/14/2008 | 65JBJ31PROGESTERONE (PROGESTIN) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Labomar Canada Inc's FDA import refusal history?
Labomar Canada Inc (FEI: 3000999767) has 39 FDA import refusal record(s) in our database, spanning from 7/14/2008 to 8/11/2025.
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. Labomar Canada Inc's FEI number is 3000999767.
What types of violations has Labomar Canada Inc received?
Labomar Canada Inc has been cited for 3 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 Labomar Canada Inc come from?
All FDA import refusal data for Labomar 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.