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Servitek Servicos Especializados Lt

⚠️ Moderate Risk

FEI: 3008574857 • Sao Jose Dos Campos, Sp • BRAZIL

FEI

FEI Number

3008574857

📍

Location

Sao Jose Dos Campos, Sp

🇧🇷

Country

BRAZIL
🏢

Address

R Guilherme De Almeida 156, , Sao Jose Dos Campos, Sp, Brazil

Moderate Risk

FDA Import Risk Assessment

30.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
10/21/2010
Latest Refusal
10/21/2010
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
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

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
10/21/2010
86LZSLASER, SYSTEM, EXCIMER
476NO REGISTR
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Servitek Servicos Especializados Lt's FDA import refusal history?

Servitek Servicos Especializados Lt (FEI: 3008574857) has 1 FDA import refusal record(s) in our database, spanning from 10/21/2010 to 10/21/2010.

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. Servitek Servicos Especializados Lt's FEI number is 3008574857.

What types of violations has Servitek Servicos Especializados Lt received?

Servitek Servicos Especializados Lt 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 Servitek Servicos Especializados Lt come from?

All FDA import refusal data for Servitek Servicos Especializados Lt 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.