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Injex Industrias Cirurgicas Ltda

⚠️ Moderate Risk

FEI: 3009061616 • Sp • BRAZIL

FEI

FEI Number

3009061616

📍

Location

Sp

🇧🇷

Country

BRAZIL
🏢

Address

Av Comendador Jose Zillo 160, , Sp, , Brazil

Moderate Risk

FDA Import Risk Assessment

27.4
LowModerateHighCritical

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

Statistics

6
Total Refusals
1
Unique Violations
9/16/2011
Latest Refusal
9/16/2011
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

3416×

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
9/16/2011
79LROKIT, SURGICAL - GENERAL
341REGISTERED
Florida District Office (FLA-DO)
9/16/2011
79LROKIT, SURGICAL - GENERAL
341REGISTERED
Florida District Office (FLA-DO)
9/16/2011
76ECBUNIT, SYRINGE, AIR AND/OR WATER
341REGISTERED
Florida District Office (FLA-DO)
9/16/2011
76ECBUNIT, SYRINGE, AIR AND/OR WATER
341REGISTERED
Florida District Office (FLA-DO)
9/16/2011
76ECBUNIT, SYRINGE, AIR AND/OR WATER
341REGISTERED
Florida District Office (FLA-DO)
9/16/2011
76ECBUNIT, SYRINGE, AIR AND/OR WATER
341REGISTERED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Injex Industrias Cirurgicas Ltda's FDA import refusal history?

Injex Industrias Cirurgicas Ltda (FEI: 3009061616) has 6 FDA import refusal record(s) in our database, spanning from 9/16/2011 to 9/16/2011.

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. Injex Industrias Cirurgicas Ltda's FEI number is 3009061616.

What types of violations has Injex Industrias Cirurgicas Ltda received?

Injex Industrias Cirurgicas 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 Injex Industrias Cirurgicas Ltda come from?

All FDA import refusal data for Injex Industrias Cirurgicas 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.