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Wenzhou Dong Long Optical Co

✅ Low Risk

FEI: 3004032474 • Guangzhou • CHINA

FEI

FEI Number

3004032474

📍

Location

Guangzhou

🇨🇳

Country

CHINA
🏢

Address

Dong Feng Ind Area Luo Qiao, , Guangzhou, , China

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/31/2008
Latest Refusal
12/31/2008
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
12/31/2008
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
118NOT LISTED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Wenzhou Dong Long Optical Co's FDA import refusal history?

Wenzhou Dong Long Optical Co (FEI: 3004032474) has 1 FDA import refusal record(s) in our database, spanning from 12/31/2008 to 12/31/2008.

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 Dong Long Optical Co's FEI number is 3004032474.

What types of violations has Wenzhou Dong Long Optical Co received?

Wenzhou Dong Long Optical Co 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 Dong Long Optical Co come from?

All FDA import refusal data for Wenzhou Dong Long Optical Co 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.