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TANGSHAN KANGJIE GLOVE CO LTD

⚠️ Moderate Risk

FEI: 3009170257 • Tangshan, Hebei • CHINA

FEI

FEI Number

3009170257

📍

Location

Tangshan, Hebei

🇨🇳

Country

CHINA
🏢

Address

Pachigang, Luannan County, Tangshan, Hebei, China

Moderate Risk

FDA Import Risk Assessment

39.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
7/24/2018
Latest Refusal
7/6/2018
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

4774×

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
7/24/2018
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Division of West Coast Imports (DWCI)
7/24/2018
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Division of West Coast Imports (DWCI)
7/24/2018
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Division of West Coast Imports (DWCI)
7/6/2018
80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY
477HOLES
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is TANGSHAN KANGJIE GLOVE CO LTD's FDA import refusal history?

TANGSHAN KANGJIE GLOVE CO LTD (FEI: 3009170257) has 4 FDA import refusal record(s) in our database, spanning from 7/6/2018 to 7/24/2018.

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. TANGSHAN KANGJIE GLOVE CO LTD's FEI number is 3009170257.

What types of violations has TANGSHAN KANGJIE GLOVE CO LTD received?

TANGSHAN KANGJIE 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 KANGJIE GLOVE CO LTD come from?

All FDA import refusal data for TANGSHAN KANGJIE 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.