Kenvue Canada Inc.
⚠️ High Risk
FEI: 1000328785 • Guelph, Ontario • CANADA
FEI Number
1000328785
Location
Guelph, Ontario
Country
CANADAAddress
890 Woodlawn Rd W, , Guelph, 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/5/2024 | 62CAL41MINOXIDIL (ANTI-HYPERTENSIVE) | Division of Northern Border Imports (DNBI) | |
| 5/24/2024 | 62KAE08LOPERAMIDE HYDROCHLORIDE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 5/24/2024 | 60SAA22FAMOTIDINE (ANTACID) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 5/24/2024 | 60SAA22FAMOTIDINE (ANTACID) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 1/6/2022 | 66VAJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 11/25/2020 | 61XDQ45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 8/4/2020 | 61XCL45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | Division of West Coast Imports (DWCI) | |
| 8/4/2020 | 61XAA45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 7/15/2020 | 61XCL45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 12/21/2016 | 55YP99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/15/2016 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | Detroit District Office (DET-DO) | |
| 12/24/2014 | 60LAY01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/3/2012 | 61TBA11MECLIZINE HCL (ANTI-EMETIC/NAUSEANT) | New Orleans District Office (NOL-DO) | |
| 4/18/2012 | 60LAS01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/18/2012 | 60LAS01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/18/2012 | 60LAS01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/17/2009 | 62UDE08CODEINE PHOSPHATE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/29/2007 | 60LDB01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/29/2007 | 60LDB01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/22/2006 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/28/2005 | 65VBA99SEDATIVE N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 7/22/2005 | 60LAA05ASPIRIN (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/19/2004 | 62UCP08CODEINE PHOSPHATE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/30/2004 | 60LBY01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Kenvue Canada Inc.'s FDA import refusal history?
Kenvue Canada Inc. (FEI: 1000328785) has 24 FDA import refusal record(s) in our database, spanning from 8/30/2004 to 8/5/2024.
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. Kenvue Canada Inc.'s FEI number is 1000328785.
What types of violations has Kenvue Canada Inc. received?
Kenvue Canada Inc. 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 Kenvue Canada Inc. come from?
All FDA import refusal data for Kenvue 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.