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Zhejiang Wanxin Optical Glasses Co., Ltd.

⚠️ Moderate Risk

FEI: 3003861534 • Zhenjiang, Jiangsu • CHINA

FEI

FEI Number

3003861534

📍

Location

Zhenjiang, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

NO 25 Guangmingzhonglu, Danyang, Zhenjiang, Jiangsu, China

Moderate Risk

FDA Import Risk Assessment

25.2
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
6/18/2012
Latest Refusal
11/13/2006
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
5.4×10%
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

2352×

NOT IMPACT

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

3412×

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).

Refusal History

DateProductViolationsDivision
6/18/2012
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
235NOT IMPACT
Division of Northeast Imports (DNEI)
6/3/2009
86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT
235NOT IMPACT
341REGISTERED
Seattle District Office (SEA-DO)
11/13/2006
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Zhejiang Wanxin Optical Glasses Co., Ltd.'s FDA import refusal history?

Zhejiang Wanxin Optical Glasses Co., Ltd. (FEI: 3003861534) has 3 FDA import refusal record(s) in our database, spanning from 11/13/2006 to 6/18/2012.

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. Zhejiang Wanxin Optical Glasses Co., Ltd.'s FEI number is 3003861534.

What types of violations has Zhejiang Wanxin Optical Glasses Co., Ltd. received?

Zhejiang Wanxin Optical Glasses 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 Zhejiang Wanxin Optical Glasses Co., Ltd. come from?

All FDA import refusal data for Zhejiang Wanxin Optical 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.