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Br Company Comercial Ltda

⚠️ Moderate Risk

FEI: 3004123251 • Sao Paulo, Sao Paulo • BRAZIL

FEI

FEI Number

3004123251

📍

Location

Sao Paulo, Sao Paulo

🇧🇷

Country

BRAZIL
🏢

Address

Rua Teixeira Leite 409c/4a, , Sao Paulo, Sao Paulo, Brazil

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/21/2003
Latest Refusal
9/21/2003
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

1151×

DR QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.

Refusal History

DateProductViolationsDivision
9/21/2003
53MD01SUNTAN GELS, CREAMS, LIQUIDS (NOT SUNSCREEN) (SUNTAN PREPARATIONS)
115DR QUALITY
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Br Company Comercial Ltda's FDA import refusal history?

Br Company Comercial Ltda (FEI: 3004123251) has 1 FDA import refusal record(s) in our database, spanning from 9/21/2003 to 9/21/2003.

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. Br Company Comercial Ltda's FEI number is 3004123251.

What types of violations has Br Company Comercial Ltda received?

Br Company Comercial 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 Br Company Comercial Ltda come from?

All FDA import refusal data for Br Company Comercial 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.