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Taizhyou City Wangye General Gasline Eagine Co Ltd

⚠️ Moderate Risk

FEI: 3009272928 • Linhai • CHINA

FEI

FEI Number

3009272928

📍

Location

Linhai

🇨🇳

Country

CHINA
🏢

Address

Shiniu Industrial, Zone Yanjiang, Linhai, , China

Moderate Risk

FDA Import Risk Assessment

33.1
LowModerateHighCritical

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

Statistics

21
Total Refusals
2
Unique Violations
5/5/2016
Latest Refusal
8/15/2012
Earliest Refusal

Score Breakdown

Violation Severity
31.4×40%
Refusal Volume
49.7×30%
Recency
0.0×20%
Frequency
56.4×10%
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

34121×

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).

2351×

NOT IMPACT

The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.

Refusal History

DateProductViolationsDivision
5/5/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Chicago District Office (CHI-DO)
5/5/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Chicago District Office (CHI-DO)
5/5/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Chicago District Office (CHI-DO)
5/5/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Chicago District Office (CHI-DO)
5/5/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Chicago District Office (CHI-DO)
5/5/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Chicago District Office (CHI-DO)
5/5/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Chicago District Office (CHI-DO)
5/5/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Chicago District Office (CHI-DO)
5/5/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Chicago District Office (CHI-DO)
5/5/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Chicago District Office (CHI-DO)
5/5/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Chicago District Office (CHI-DO)
5/5/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Chicago District Office (CHI-DO)
5/5/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Chicago District Office (CHI-DO)
5/5/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Chicago District Office (CHI-DO)
5/5/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Chicago District Office (CHI-DO)
5/5/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Chicago District Office (CHI-DO)
5/5/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Chicago District Office (CHI-DO)
5/5/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Chicago District Office (CHI-DO)
5/5/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Chicago District Office (CHI-DO)
5/5/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Chicago District Office (CHI-DO)
8/15/2012
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Taizhyou City Wangye General Gasline Eagine Co Ltd's FDA import refusal history?

Taizhyou City Wangye General Gasline Eagine Co Ltd (FEI: 3009272928) has 21 FDA import refusal record(s) in our database, spanning from 8/15/2012 to 5/5/2016.

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. Taizhyou City Wangye General Gasline Eagine Co Ltd's FEI number is 3009272928.

What types of violations has Taizhyou City Wangye General Gasline Eagine Co Ltd received?

Taizhyou City Wangye General Gasline Eagine 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 Taizhyou City Wangye General Gasline Eagine Co Ltd come from?

All FDA import refusal data for Taizhyou City Wangye General Gasline Eagine 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.