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Wenzhou Dongou Glasses Co., Ltd.

⚠️ Moderate Risk

FEI: 3003504145 • Wenzhou, Zhejiang • CHINA

FEI

FEI Number

3003504145

📍

Location

Wenzhou, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

Lucheng Yanjiang, No. 31 Yanfan Road; Yangyixiang Lucheng, Wenzhou, Zhejiang, 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
10/29/2013
Latest Refusal
10/29/2013
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

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

Refusal History

DateProductViolationsDivision
10/29/2013
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
126FAILS STD
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Wenzhou Dongou Glasses Co., Ltd.'s FDA import refusal history?

Wenzhou Dongou Glasses Co., Ltd. (FEI: 3003504145) has 1 FDA import refusal record(s) in our database, spanning from 10/29/2013 to 10/29/2013.

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. Wenzhou Dongou Glasses Co., Ltd.'s FEI number is 3003504145.

What types of violations has Wenzhou Dongou Glasses Co., Ltd. received?

Wenzhou Dongou Glasses 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 Wenzhou Dongou Glasses Co., Ltd. come from?

All FDA import refusal data for Wenzhou Dongou Glasses 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.