HK Kolmar Canada, Inc.
⚠️ High Risk
FEI: 3002647523 • Barrie, Ontario • CANADA
FEI Number
3002647523
Location
Barrie, Ontario
Country
CANADAAddress
149 Victoria St, , Barrie, 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
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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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).
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.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/6/2024 | 61WAJ99A-FUNGAL N.E.C. | Division of Northern Border Imports (DNBI) | |
| 12/6/2024 | 61WAJ99A-FUNGAL N.E.C. | Division of Northern Border Imports (DNBI) | |
| 12/6/2024 | 61WAJ99A-FUNGAL N.E.C. | Division of Northern Border Imports (DNBI) | |
| 1/13/2016 | 53CD04EYE LOTION (EYE MAKEUP PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/18/2014 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) | |
| 2/20/2013 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 2/20/2013 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 2/20/2013 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 2/20/2013 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 2/20/2013 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 2/20/2013 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 6/19/2012 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/16/2011 | 55QY46SODIUM FORMALDEHYDE SULFOXYLATE (PHARMACEUTIC NECESSITY - PRESERVATIVE) | Detroit District Office (DET-DO) | |
| 9/17/2009 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New York District Office (NYK-DO) | |
| 9/17/2009 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New York District Office (NYK-DO) | |
| 3/21/2007 | 64UKJ99INHIBITOR N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/5/2003 | 66PAQ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is HK Kolmar Canada, Inc.'s FDA import refusal history?
HK Kolmar Canada, Inc. (FEI: 3002647523) has 17 FDA import refusal record(s) in our database, spanning from 8/5/2003 to 12/6/2024.
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. HK Kolmar Canada, Inc.'s FEI number is 3002647523.
What types of violations has HK Kolmar Canada, Inc. received?
HK Kolmar Canada, Inc. has been cited for 12 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 HK Kolmar Canada, Inc. come from?
All FDA import refusal data for HK Kolmar 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.