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FLEX GUADALAJARA NORTH

⚠️ High Risk

FEI: 3025895144 • Zapopan • MEXICO

FEI

FEI Number

3025895144

📍

Location

Zapopan

🇲🇽

Country

MEXICO
🏢

Address

Libramiento Care 5850-4, , Zapopan, , Mexico

High Risk

FDA Import Risk Assessment

58.7
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

13
Total Refusals
2
Unique Violations
1/16/2024
Latest Refusal
7/17/2023
Earliest Refusal

Score Breakdown

Violation Severity
66.9×40%
Refusal Volume
42.5×30%
Recency
46.2×20%
Frequency
100.0×10%
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

479×

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.

4764×

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
1/16/2024
95RFNFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER
47NON STD
Division of Southeast Imports (DSEI)
1/16/2024
95RFNFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER
47NON STD
Division of Southeast Imports (DSEI)
1/16/2024
95RFNFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER
47NON STD
Division of Southeast Imports (DSEI)
1/16/2024
95RFNFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER
47NON STD
Division of Southeast Imports (DSEI)
1/16/2024
95RFNFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER
47NON STD
Division of Southeast Imports (DSEI)
1/16/2024
95RFNFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER
47NON STD
Division of Southeast Imports (DSEI)
1/16/2024
95RFNFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER
47NON STD
Division of Southeast Imports (DSEI)
1/16/2024
95RFNFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER
47NON STD
Division of Southeast Imports (DSEI)
12/11/2023
95RFNFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER
476NO REGISTR
Division of West Coast Imports (DWCI)
12/6/2023
95RFNFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER
476NO REGISTR
Division of Northeast Imports (DNEI)
12/6/2023
95RFNFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER
476NO REGISTR
Division of Northeast Imports (DNEI)
12/6/2023
95RFNFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER
476NO REGISTR
Division of Northeast Imports (DNEI)
7/17/2023
95RFNFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER
47NON STD
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is FLEX GUADALAJARA NORTH's FDA import refusal history?

FLEX GUADALAJARA NORTH (FEI: 3025895144) has 13 FDA import refusal record(s) in our database, spanning from 7/17/2023 to 1/16/2024.

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. FLEX GUADALAJARA NORTH's FEI number is 3025895144.

What types of violations has FLEX GUADALAJARA NORTH received?

FLEX GUADALAJARA NORTH 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 FLEX GUADALAJARA NORTH come from?

All FDA import refusal data for FLEX GUADALAJARA NORTH 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.