ImportRefusal LogoImportRefusal

Wenzhou Donglong Optical Glasses Co. Ltd

✅ Low Risk

FEI: 3007738485 • Wenzhou, Zhejiang • CHINA

FEI

FEI Number

3007738485

📍

Location

Wenzhou, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

Louqiao, Dongfenggongye, Wenzhou, Zhejiang, 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
3/30/2016
Latest Refusal
3/30/2016
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

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
3/30/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
3280FRNMFGREG
Philadelphia District Office (PHI-DO)

Frequently Asked Questions

What is Wenzhou Donglong Optical Glasses Co. Ltd's FDA import refusal history?

Wenzhou Donglong Optical Glasses Co. Ltd (FEI: 3007738485) has 1 FDA import refusal record(s) in our database, spanning from 3/30/2016 to 3/30/2016.

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 Donglong Optical Glasses Co. Ltd's FEI number is 3007738485.

What types of violations has Wenzhou Donglong Optical Glasses Co. Ltd received?

Wenzhou Donglong Optical Glasses 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 Donglong Optical Glasses Co. Ltd come from?

All FDA import refusal data for Wenzhou Donglong 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.