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Shandong Jianhong New Material Company

⚠️ Moderate Risk

FEI: 3009514047 • Zibo, Shandong • CHINA

FEI

FEI Number

3009514047

📍

Location

Zibo, Shandong

🇨🇳

Country

CHINA
🏢

Address

Xisha, Guoli Town, Huantai County, Zibo, Shandong, China

Moderate Risk

FDA Import Risk Assessment

41.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
12/3/2018
Latest Refusal
12/3/2018
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

4775×

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
12/3/2018
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Division of Southeast Imports (DSEI)
12/3/2018
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Division of Southeast Imports (DSEI)
12/3/2018
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Division of Southeast Imports (DSEI)
12/3/2018
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Division of Southeast Imports (DSEI)
12/3/2018
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Shandong Jianhong New Material Company's FDA import refusal history?

Shandong Jianhong New Material Company (FEI: 3009514047) has 5 FDA import refusal record(s) in our database, spanning from 12/3/2018 to 12/3/2018.

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. Shandong Jianhong New Material Company's FEI number is 3009514047.

What types of violations has Shandong Jianhong New Material Company received?

Shandong Jianhong New Material Company 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 Shandong Jianhong New Material Company come from?

All FDA import refusal data for Shandong Jianhong New Material Company 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.