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Wenzhou Jintai Optical Co., Ltd

✅ Low Risk

FEI: 3009670929 • Wenzhou • CHINA

FEI

FEI Number

3009670929

📍

Location

Wenzhou

🇨🇳

Country

CHINA
🏢

Address

No. 278 Yuteng Rdlight Industry Zone,, , Wenzhou, , China

Low Risk

FDA Import Risk Assessment

22.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
8/30/2012
Latest Refusal
8/30/2012
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
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.

3411×

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
8/30/2012
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

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

Wenzhou Jintai Optical Co., Ltd (FEI: 3009670929) has 1 FDA import refusal record(s) in our database, spanning from 8/30/2012 to 8/30/2012.

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. Wenzhou Jintai Optical Co., Ltd's FEI number is 3009670929.

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

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

All FDA import refusal data for Wenzhou Jintai 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.