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Labor Line Ind.E Com. De Equipament

✅ Low Risk

FEI: 3009530298 • Barueri, Sao Paulo • BRAZIL

FEI

FEI Number

3009530298

📍

Location

Barueri, Sao Paulo

🇧🇷

Country

BRAZIL
🏢

Address

Alameda Tocantins 755, , Barueri, Sao Paulo, Brazil

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
7/8/2013
Latest Refusal
7/8/2013
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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

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).

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
7/8/2013
75JQCCENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE
118NOT LISTED
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Labor Line Ind.E Com. De Equipament's FDA import refusal history?

Labor Line Ind.E Com. De Equipament (FEI: 3009530298) has 1 FDA import refusal record(s) in our database, spanning from 7/8/2013 to 7/8/2013.

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. Labor Line Ind.E Com. De Equipament's FEI number is 3009530298.

What types of violations has Labor Line Ind.E Com. De Equipament received?

Labor Line Ind.E Com. De Equipament 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 Labor Line Ind.E Com. De Equipament come from?

All FDA import refusal data for Labor Line Ind.E Com. De Equipament 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.