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Genetex

⚠️ Moderate Risk

FEI: 3008683727 • Hsinchu City • TAIWAN

FEI

FEI Number

3008683727

📍

Location

Hsinchu City

🇹🇼

Country

TAIWAN
🏢

Address

NO. 89., 3f-2, Dongmei Rd.; East Dist., Hsinchu City, , Taiwan

Moderate Risk

FDA Import Risk Assessment

35.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
9/19/2018
Latest Refusal
9/19/2018
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

2234×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

Refusal History

DateProductViolationsDivision
9/19/2018
57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.
223FALSE
Division of Southeast Imports (DSEI)
9/19/2018
57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.
223FALSE
Division of Southeast Imports (DSEI)
9/19/2018
57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.
223FALSE
Division of Southeast Imports (DSEI)
9/19/2018
57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.
223FALSE
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Genetex's FDA import refusal history?

Genetex (FEI: 3008683727) has 4 FDA import refusal record(s) in our database, spanning from 9/19/2018 to 9/19/2018.

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. Genetex's FEI number is 3008683727.

What types of violations has Genetex received?

Genetex 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 Genetex come from?

All FDA import refusal data for Genetex 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.