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3M Thailand Limited-Branch

⚠️ Moderate Risk

FEI: 3002779788 • Lat Lum Kaeo, Pathum Thani • THAILAND

FEI

FEI Number

3002779788

📍

Location

Lat Lum Kaeo, Pathum Thani

🇹🇭

Country

THAILAND
🏢

Address

53/1 Moo 1, Soi Sukhapiban 2, , Lat Lum Kaeo, Pathum Thani, Thailand

Moderate Risk

FDA Import Risk Assessment

25.5
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
5/27/2015
Latest Refusal
9/28/2011
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
8.2×10%
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

1183×

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).

3411×

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

DateProductViolationsDivision
5/27/2015
79KGXTAPE AND BANDAGE, ADHESIVE
118NOT LISTED
341REGISTERED
Los Angeles District Office (LOS-DO)
9/28/2011
79KGXTAPE AND BANDAGE, ADHESIVE
118NOT LISTED
Los Angeles District Office (LOS-DO)
9/28/2011
89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC
118NOT LISTED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is 3M Thailand Limited-Branch's FDA import refusal history?

3M Thailand Limited-Branch (FEI: 3002779788) has 3 FDA import refusal record(s) in our database, spanning from 9/28/2011 to 5/27/2015.

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 Thailand Limited-Branch's FEI number is 3002779788.

What types of violations has 3M Thailand Limited-Branch received?

3M Thailand Limited-Branch has been cited for 2 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 Thailand Limited-Branch come from?

All FDA import refusal data for 3M Thailand Limited-Branch 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.