ImportRefusal LogoImportRefusal

3M DO BRASIL LTDA

⚠️ Moderate Risk

FEI: 3005360729 • Sao Jose Do Rio Preto, Sao Paulo • BRAZIL

FEI

FEI Number

3005360729

📍

Location

Sao Jose Do Rio Preto, Sao Paulo

🇧🇷

Country

BRAZIL
🏢

Address

Avenida Gerassina Tavares, 750, Jd. Yolanda, Sao Jose Do Rio Preto, Sao Paulo, Brazil

Moderate Risk

FDA Import Risk Assessment

27.5
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
8/19/2009
Latest Refusal
12/2/2005
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
8.1×10%
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).

Refusal History

DateProductViolationsDivision
8/19/2009
76NRDUNIT, OPERATIVE DENTAL, ACCESSORIES
118NOT LISTED
New Orleans District Office (NOL-DO)
8/19/2009
76DZDTUBE, ORTHODONTIC
118NOT LISTED
New Orleans District Office (NOL-DO)
12/2/2005
76DZDTUBE, ORTHODONTIC
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is 3M DO BRASIL LTDA's FDA import refusal history?

3M DO BRASIL LTDA (FEI: 3005360729) has 3 FDA import refusal record(s) in our database, spanning from 12/2/2005 to 8/19/2009.

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 DO BRASIL LTDA's FEI number is 3005360729.

What types of violations has 3M DO BRASIL LTDA received?

3M DO BRASIL LTDA 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 DO BRASIL LTDA come from?

All FDA import refusal data for 3M DO BRASIL LTDA 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.