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SYSCOMEX CMERCIAL IMPORTADORA EX

⚠️ Moderate Risk

FEI: 3012288026 • Sao Paulo • BRAZIL

FEI

FEI Number

3012288026

📍

Location

Sao Paulo

🇧🇷

Country

BRAZIL
🏢

Address

Rua Parque Domingos Lui, , Sao Paulo, , Brazil

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
7/18/2023
Latest Refusal
7/18/2023
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
11.2×30%
Recency
49.7×20%
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

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

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).

Refusal History

DateProductViolationsDivision
7/18/2023
95RFELASER CUTTER, MATERIAL PROCESSING LASER PRODUCTS
47NON STD
476NO REGISTR
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SYSCOMEX CMERCIAL IMPORTADORA EX's FDA import refusal history?

SYSCOMEX CMERCIAL IMPORTADORA EX (FEI: 3012288026) has 1 FDA import refusal record(s) in our database, spanning from 7/18/2023 to 7/18/2023.

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. SYSCOMEX CMERCIAL IMPORTADORA EX's FEI number is 3012288026.

What types of violations has SYSCOMEX CMERCIAL IMPORTADORA EX received?

SYSCOMEX CMERCIAL IMPORTADORA EX 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 SYSCOMEX CMERCIAL IMPORTADORA EX come from?

All FDA import refusal data for SYSCOMEX CMERCIAL IMPORTADORA EX 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.