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WENZHOU SUMMER INTERNATIONAL LIMITED

⚠️ Moderate Risk

FEI: 3010329856 • Wenzhou, Zhejiang • CHINA

FEI

FEI Number

3010329856

📍

Location

Wenzhou, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

Room 201, NO. 24 Liming Industrial, Wenzhou, Zhejiang, China

Moderate Risk

FDA Import Risk Assessment

31.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
9/14/2015
Latest Refusal
2/11/2015
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

2354×

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
9/14/2015
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
341REGISTERED
Cincinnati District Office (CIN-DO)
5/5/2015
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
Division of Southeast Imports (DSEI)
3/16/2015
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
New Orleans District Office (NOL-DO)
2/11/2015
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is WENZHOU SUMMER INTERNATIONAL LIMITED's FDA import refusal history?

WENZHOU SUMMER INTERNATIONAL LIMITED (FEI: 3010329856) has 4 FDA import refusal record(s) in our database, spanning from 2/11/2015 to 9/14/2015.

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. WENZHOU SUMMER INTERNATIONAL LIMITED's FEI number is 3010329856.

What types of violations has WENZHOU SUMMER INTERNATIONAL LIMITED received?

WENZHOU SUMMER INTERNATIONAL LIMITED 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 WENZHOU SUMMER INTERNATIONAL LIMITED come from?

All FDA import refusal data for WENZHOU SUMMER INTERNATIONAL LIMITED 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.