3M Canada Inc.
⚠️ Moderate Risk
FEI: 1000283504 • London, Ontario • CANADA
FEI Number
1000283504
Location
London, Ontario
Country
CANADAAddress
1840 Oxford St E, , London, Ontario, Canada
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/26/2017 | 79OHOFIRST AID KIT WITHOUT DRUG | Division of Southeast Imports (DSEI) | |
| 7/26/2012 | 80JOJINDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS | 508NO 510(K) | Detroit District Office (DET-DO) |
| 5/11/2012 | 74DRXELECTRODE, ELECTROCARDIOGRAPH | New Orleans District Office (NOL-DO) | |
| 5/11/2012 | 74DRXELECTRODE, ELECTROCARDIOGRAPH | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is 3M Canada Inc.'s FDA import refusal history?
3M Canada Inc. (FEI: 1000283504) has 4 FDA import refusal record(s) in our database, spanning from 5/11/2012 to 9/26/2017.
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. 3M Canada Inc.'s FEI number is 1000283504.
What types of violations has 3M Canada Inc. received?
3M 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 3M Canada Inc. come from?
All FDA import refusal data for 3M 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.