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Tangshan Kangyuan Glove Co Ltd

⚠️ Moderate Risk

FEI: 3008177918 • Tangshan • CHINA

FEI

FEI Number

3008177918

📍

Location

Tangshan

🇨🇳

Country

CHINA
🏢

Address

Linqing Road, Luannan, , Tangshan, , China

Moderate Risk

FDA Import Risk Assessment

48.1
LowModerateHighCritical

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

Statistics

9
Total Refusals
1
Unique Violations
10/16/2013
Latest Refusal
1/11/2013
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
37.0×30%
Recency
0.0×20%
Frequency
90.0×10%
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

4779×

HOLES

The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.

Refusal History

DateProductViolationsDivision
10/16/2013
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Chicago District Office (CHI-DO)
3/6/2013
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Minneapolis District Office (MIN-DO)
3/6/2013
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Minneapolis District Office (MIN-DO)
3/6/2013
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Minneapolis District Office (MIN-DO)
3/5/2013
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Seattle District Office (SEA-DO)
3/5/2013
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Seattle District Office (SEA-DO)
3/5/2013
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Seattle District Office (SEA-DO)
3/5/2013
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Seattle District Office (SEA-DO)
1/11/2013
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Minneapolis District Office (MIN-DO)

Frequently Asked Questions

What is Tangshan Kangyuan Glove Co Ltd's FDA import refusal history?

Tangshan Kangyuan Glove Co Ltd (FEI: 3008177918) has 9 FDA import refusal record(s) in our database, spanning from 1/11/2013 to 10/16/2013.

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. Tangshan Kangyuan Glove Co Ltd's FEI number is 3008177918.

What types of violations has Tangshan Kangyuan Glove Co Ltd received?

Tangshan Kangyuan Glove Co Ltd 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 Tangshan Kangyuan Glove Co Ltd come from?

All FDA import refusal data for Tangshan Kangyuan Glove Co Ltd 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.