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ZIBO CHENGXUN AUTOMATIC DEVICE CO., LTD

⚠️ Moderate Risk

FEI: 3013576504 • Zibo, Shandong • CHINA

FEI

FEI Number

3013576504

📍

Location

Zibo, Shandong

🇨🇳

Country

CHINA
🏢

Address

NO. 37 Minan Road, High-Tech Industrial, Zibo, Shandong, China

Moderate Risk

FDA Import Risk Assessment

43.2
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/10/2023
Latest Refusal
10/10/2023
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
54.4×20%
Frequency
10.0×10%
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

4771×

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
10/10/2023
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is ZIBO CHENGXUN AUTOMATIC DEVICE CO., LTD's FDA import refusal history?

ZIBO CHENGXUN AUTOMATIC DEVICE CO., LTD (FEI: 3013576504) has 1 FDA import refusal record(s) in our database, spanning from 10/10/2023 to 10/10/2023.

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. ZIBO CHENGXUN AUTOMATIC DEVICE CO., LTD's FEI number is 3013576504.

What types of violations has ZIBO CHENGXUN AUTOMATIC DEVICE CO., LTD received?

ZIBO CHENGXUN AUTOMATIC DEVICE 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 ZIBO CHENGXUN AUTOMATIC DEVICE CO., LTD come from?

All FDA import refusal data for ZIBO CHENGXUN AUTOMATIC DEVICE 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.