Mcneil Consumer Healthcare
⚠️ High Risk
FEI: 3006989916 • Markham, Ontario • CANADA
FEI Number
3006989916
Location
Markham, Ontario
Country
CANADAAddress
88 McNabb St, , Markham, 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).
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).
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 |
|---|---|---|---|
| 2/18/2025 | 66BAY44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/10/2025 | 66BAY44NICOTINE DELIVERY SYSTEM | Division of Southeast Imports (DSEI) | |
| 2/10/2025 | 66BAY44NICOTINE DELIVERY SYSTEM | Division of Southeast Imports (DSEI) | |
| 6/21/2024 | 62KAY08LOPERAMIDE HYDROCHLORIDE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 9/27/2022 | 66BBY44NICOTINE DELIVERY SYSTEM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/27/2022 | 66BBY44NICOTINE DELIVERY SYSTEM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/12/2020 | 60LAB01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 6/14/2016 | 60LBL01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 9/8/2010 | 66BAY44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 11/6/2009 | 66BIY44NICOTINE DELIVERY SYSTEM | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Mcneil Consumer Healthcare's FDA import refusal history?
Mcneil Consumer Healthcare (FEI: 3006989916) has 10 FDA import refusal record(s) in our database, spanning from 11/6/2009 to 2/18/2025.
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. Mcneil Consumer Healthcare's FEI number is 3006989916.
What types of violations has Mcneil Consumer Healthcare received?
Mcneil Consumer Healthcare 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 Mcneil Consumer Healthcare come from?
All FDA import refusal data for Mcneil Consumer Healthcare 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.