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Wing Chun Indsuirla Co Ltd

⚠️ Moderate Risk

FEI: 3009544241 • Shenzhenshenzhen • CHINA

FEI

FEI Number

3009544241

📍

Location

Shenzhenshenzhen

🇨🇳

Country

CHINA
🏢

Address

Bldg 2 Yuzu Fen Indziral Zone, , Shenzhenshenzhen, , China

Moderate Risk

FDA Import Risk Assessment

33.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
2/23/2015
Latest Refusal
2/23/2015
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

3415×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

5085×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
2/23/2015
76EFWTOOTHBRUSH, MANUAL
341REGISTERED
508NO 510(K)
Los Angeles District Office (LOS-DO)
2/23/2015
76JEQTOOTHBRUSH, POWERED
341REGISTERED
508NO 510(K)
Los Angeles District Office (LOS-DO)
2/23/2015
76JEQTOOTHBRUSH, POWERED
341REGISTERED
508NO 510(K)
Los Angeles District Office (LOS-DO)
2/23/2015
76EFWTOOTHBRUSH, MANUAL
341REGISTERED
508NO 510(K)
Los Angeles District Office (LOS-DO)
2/23/2015
76JEQTOOTHBRUSH, POWERED
341REGISTERED
508NO 510(K)
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Wing Chun Indsuirla Co Ltd's FDA import refusal history?

Wing Chun Indsuirla Co Ltd (FEI: 3009544241) has 5 FDA import refusal record(s) in our database, spanning from 2/23/2015 to 2/23/2015.

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. Wing Chun Indsuirla Co Ltd's FEI number is 3009544241.

What types of violations has Wing Chun Indsuirla Co Ltd received?

Wing Chun Indsuirla Co Ltd has been cited for 2 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 Wing Chun Indsuirla Co Ltd come from?

All FDA import refusal data for Wing Chun Indsuirla 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.