HALEON
⚠️ High Risk
FEI: 3024306869 • Mississauga, Ontario • CANADA
FEI Number
3024306869
Location
Mississauga, Ontario
Country
CANADAAddress
55 Standish Crt, , Mississauga, 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).
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.
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/29/2025 | 62UCL11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | Division of Northern Border Imports (DNBI) | |
| 10/3/2025 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Northern Border Imports (DNBI) | |
| 6/4/2025 | 60LAA01ACETAMINOPHEN (ANALGESIC) | Division of Southeast Imports (DSEI) | |
| 11/13/2024 | 60LAY01ACETAMINOPHEN (ANALGESIC) | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is HALEON's FDA import refusal history?
HALEON (FEI: 3024306869) has 4 FDA import refusal record(s) in our database, spanning from 11/13/2024 to 10/29/2025.
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. HALEON's FEI number is 3024306869.
What types of violations has HALEON received?
HALEON has been cited for 6 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 HALEON come from?
All FDA import refusal data for HALEON 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.