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Kangtex & Associates Inc

⚠️ Moderate Risk

FEI: 1000140817 • Taipei • TAIWAN

FEI

FEI Number

1000140817

📍

Location

Taipei

🇹🇼

Country

TAIWAN
🏢

Address

4f 419-1 Jenai Rd Sec 4, , Taipei, , Taiwan

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
7/9/2003
Latest Refusal
9/11/2002
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

111×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
7/9/2003
53GC05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
11UNSAFE COL
Atlanta District Office (ATL-DO)
9/11/2002
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Kangtex & Associates Inc's FDA import refusal history?

Kangtex & Associates Inc (FEI: 1000140817) has 2 FDA import refusal record(s) in our database, spanning from 9/11/2002 to 7/9/2003.

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. Kangtex & Associates Inc's FEI number is 1000140817.

What types of violations has Kangtex & Associates Inc received?

Kangtex & Associates Inc 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 Kangtex & Associates Inc come from?

All FDA import refusal data for Kangtex & Associates Inc 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.