3M Company
⚠️ High Risk
FEI: 2110898 • Saint Paul, MN • UNITED STATES
FEI Number
2110898
Location
Saint Paul, MN
Country
UNITED STATESAddress
2510 Conway Ave E, 3m Center, Building 275-5w-06, Saint Paul, MN, United States
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).
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.
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.
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).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/19/2025 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
| 7/21/2021 | 76EMACEMENT, DENTAL | Division of Southeast Imports (DSEI) | |
| 11/20/2020 | 76KLEAGENT, TOOTH BONDING, RESIN | Division of Northern Border Imports (DNBI) | |
| 9/30/2018 | 76EJRAGENT, POLISHING, ABRASIVE, ORAL CAVITY | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/23/2016 | 66GDY25DIMETHICONE 350 (SURGICAL/PROSTHETIC AID) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 6/24/2016 | 79GDTSTAPLE, REMOVABLE (SKIN) | 3280FRNMFGREG | Florida District Office (FLA-DO) |
| 11/24/2014 | 76ELWMATERIAL, IMPRESSION | New York District Office (NYK-DO) | |
| 11/24/2014 | 76ELWMATERIAL, IMPRESSION | New York District Office (NYK-DO) | |
| 12/20/2013 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 9/19/2013 | 79KGXTAPE AND BANDAGE, ADHESIVE | Atlanta District Office (ATL-DO) | |
| 8/24/2011 | 80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE | New England District Office (NWE-DO) | |
| 8/24/2011 | 79KGOSURGEON'S GLOVES | New England District Office (NWE-DO) | |
| 2/23/2011 | 76EMACEMENT, DENTAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/3/2010 | 77EWEPROTECTOR, HEARING (CIRCUMAURAL) | 476NO REGISTR | Southwest Import District Office (SWI-DO) |
| 9/1/2010 | 74MLNELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION | Minneapolis District Office (MIN-DO) | |
| 11/23/2009 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 12/12/2006 | 76EJISYRINGE, CARTRIDGE | New York District Office (NYK-DO) | |
| 10/20/2006 | 76EJISYRINGE, CARTRIDGE | 118NOT LISTED | New York District Office (NYK-DO) |
| 6/28/2006 | 76EBDCOATING, FILLING MATERIAL, RESIN | 118NOT LISTED | New York District Office (NYK-DO) |
| 6/28/2006 | 76EBDCOATING, FILLING MATERIAL, RESIN | 118NOT LISTED | New York District Office (NYK-DO) |
| 6/19/2006 | 76EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 6/19/2006 | 76EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 6/19/2006 | 76DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN | 118NOT LISTED | New York District Office (NYK-DO) |
| 6/19/2006 | 76EMACEMENT, DENTAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 6/19/2006 | 76EMACEMENT, DENTAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 6/19/2006 | 76EMACEMENT, DENTAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 6/19/2006 | 76EMACEMENT, DENTAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 6/19/2006 | 76EMACEMENT, DENTAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 6/19/2006 | 76EMACEMENT, DENTAL | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is 3M Company's FDA import refusal history?
3M Company (FEI: 2110898) has 29 FDA import refusal record(s) in our database, spanning from 6/19/2006 to 9/19/2025.
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. 3M Company's FEI number is 2110898.
What types of violations has 3M Company received?
3M Company 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 3M Company come from?
All FDA import refusal data for 3M Company 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.