ImportRefusal LogoImportRefusal

3M Company

⚠️ Moderate Risk

FEI: 1484185 • Cordova, IL • UNITED STATES

FEI

FEI Number

1484185

📍

Location

Cordova, IL

🇺🇸
🏢

Address

22614 Route 84 N Bldg 3and23, , Cordova, IL, United States

Moderate Risk

FDA Import Risk Assessment

42.4
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

12
Total Refusals
1
Unique Violations
8/10/2011
Latest Refusal
6/8/2011
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
41.3×30%
Recency
0.0×20%
Frequency
100.0×10%
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

11812×

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).

Refusal History

DateProductViolationsDivision
8/10/2011
62FBK20IODINE (ANTI-INFECTIVE, TOPICAL)
118NOT LISTED
Southwest Import District Office (SWI-DO)
8/10/2011
62FBK20IODINE (ANTI-INFECTIVE, TOPICAL)
118NOT LISTED
Southwest Import District Office (SWI-DO)
8/10/2011
62FBK20IODINE (ANTI-INFECTIVE, TOPICAL)
118NOT LISTED
Southwest Import District Office (SWI-DO)
8/10/2011
62FBK20IODINE (ANTI-INFECTIVE, TOPICAL)
118NOT LISTED
Southwest Import District Office (SWI-DO)
8/10/2011
62FBK20IODINE (ANTI-INFECTIVE, TOPICAL)
118NOT LISTED
Southwest Import District Office (SWI-DO)
8/10/2011
62FBK20IODINE (ANTI-INFECTIVE, TOPICAL)
118NOT LISTED
Southwest Import District Office (SWI-DO)
8/10/2011
62FBK20IODINE (ANTI-INFECTIVE, TOPICAL)
118NOT LISTED
Southwest Import District Office (SWI-DO)
6/21/2011
62FBK20IODINE (ANTI-INFECTIVE, TOPICAL)
118NOT LISTED
Southwest Import District Office (SWI-DO)
6/21/2011
62FBK20IODINE (ANTI-INFECTIVE, TOPICAL)
118NOT LISTED
Southwest Import District Office (SWI-DO)
6/21/2011
62FBK20IODINE (ANTI-INFECTIVE, TOPICAL)
118NOT LISTED
Southwest Import District Office (SWI-DO)
6/8/2011
62FBK20IODINE (ANTI-INFECTIVE, TOPICAL)
118NOT LISTED
Southwest Import District Office (SWI-DO)
6/8/2011
62FBK20IODINE (ANTI-INFECTIVE, TOPICAL)
118NOT LISTED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is 3M Company's FDA import refusal history?

3M Company (FEI: 1484185) has 12 FDA import refusal record(s) in our database, spanning from 6/8/2011 to 8/10/2011.

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 1484185.

What types of violations has 3M Company received?

3M Company has been cited for 1 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.