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Wenzhou Royal Optical Co., Ltd

⚠️ Moderate Risk

FEI: 3006755664 • Zhejiang • CHINA

FEI

FEI Number

3006755664

📍

Location

Zhejiang

🇨🇳

Country

CHINA
🏢

Address

# the First Unit, 194 Cihu Road,Wutian; Wenzhou, Zhejiang, , China

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/18/2013
Latest Refusal
12/18/2013
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

2351×

NOT IMPACT

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

Refusal History

DateProductViolationsDivision
12/18/2013
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Wenzhou Royal Optical Co., Ltd's FDA import refusal history?

Wenzhou Royal Optical Co., Ltd (FEI: 3006755664) has 1 FDA import refusal record(s) in our database, spanning from 12/18/2013 to 12/18/2013.

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 Royal Optical Co., Ltd's FEI number is 3006755664.

What types of violations has Wenzhou Royal Optical Co., Ltd received?

Wenzhou Royal Optical 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 Royal Optical Co., Ltd come from?

All FDA import refusal data for Wenzhou Royal Optical 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.