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Sax Logistica De Shows Eventos Ltda

✅ Low Risk

FEI: 3005845521 • Rio de Janeiro, Rio de Janeiro • BRAZIL

FEI

FEI Number

3005845521

📍

Location

Rio de Janeiro, Rio de Janeiro

🇧🇷

Country

BRAZIL
🏢

Address

Praca Coronel Castelo Branco 94, Sobreloja S, Rio de Janeiro, Rio de Janeiro, Brazil

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/23/2006
Latest Refusal
8/23/2006
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

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
8/23/2006
78MOAANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)
341REGISTERED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Sax Logistica De Shows Eventos Ltda's FDA import refusal history?

Sax Logistica De Shows Eventos Ltda (FEI: 3005845521) has 1 FDA import refusal record(s) in our database, spanning from 8/23/2006 to 8/23/2006.

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. Sax Logistica De Shows Eventos Ltda's FEI number is 3005845521.

What types of violations has Sax Logistica De Shows Eventos Ltda received?

Sax Logistica De Shows Eventos 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 Sax Logistica De Shows Eventos Ltda come from?

All FDA import refusal data for Sax Logistica De Shows Eventos 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.