ImportRefusal LogoImportRefusal

Wendeng Sung Chang Intal Co.,Ltd

⚠️ Moderate Risk

FEI: 3008061964 • Weihai, Shandong • CHINA

FEI

FEI Number

3008061964

📍

Location

Weihai, Shandong

🇨🇳

Country

CHINA
🏢

Address

# 58 Wang Cheng Way Wang Cheng Tw, , Weihai, Shandong, China

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/11/2012
Latest Refusal
6/11/2012
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

4801×

STAINSTEEL

The article appears to be a device whose quality falls below that which it purports or is represented to possess, in that instrument is represented as stainless steel but does not meet requirements for such steel for surgical instruments.

Refusal History

DateProductViolationsDivision
6/11/2012
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
480STAINSTEEL
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Wendeng Sung Chang Intal Co.,Ltd's FDA import refusal history?

Wendeng Sung Chang Intal Co.,Ltd (FEI: 3008061964) has 1 FDA import refusal record(s) in our database, spanning from 6/11/2012 to 6/11/2012.

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. Wendeng Sung Chang Intal Co.,Ltd's FEI number is 3008061964.

What types of violations has Wendeng Sung Chang Intal Co.,Ltd received?

Wendeng Sung Chang Intal 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 Wendeng Sung Chang Intal Co.,Ltd come from?

All FDA import refusal data for Wendeng Sung Chang Intal 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.