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FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDA

⚠️ Moderate Risk

FEI: 3006427656 • Taubate, Sao Paulo • BRAZIL

FEI

FEI Number

3006427656

📍

Location

Taubate, Sao Paulo

🇧🇷

Country

BRAZIL
🏢

Address

Rua Joao Porfirio Macedo, 401, Rua Engenheiro Joao Porfirio De Macedo 401, Taubate, Sao Paulo, Brazil

Moderate Risk

FDA Import Risk Assessment

36.4
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
9/30/2025
Latest Refusal
9/30/2025
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
80.1×20%
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

1181×

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).

32601×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)

Refusal History

DateProductViolationsDivision
9/30/2025
80FMINEEDLE, HYPODERMIC, SINGLE LUMEN
118NOT LISTED
3260NO ENGLISH
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDA's FDA import refusal history?

FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDA (FEI: 3006427656) has 1 FDA import refusal record(s) in our database, spanning from 9/30/2025 to 9/30/2025.

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. FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDA's FEI number is 3006427656.

What types of violations has FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDA received?

FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDA 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 FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDA come from?

All FDA import refusal data for FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO 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.