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Dongguan Hamwell Glasses Co

⚠️ Moderate Risk

FEI: 1000648085 • Dongguan • CHINA

FEI

FEI Number

1000648085

📍

Location

Dongguan

🇨🇳

Country

CHINA
🏢

Address

Prowin Commerical Centre, , Dongguan, , China

Moderate Risk

FDA Import Risk Assessment

33.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
2/29/2012
Latest Refusal
2/29/2012
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

2353×

NOT IMPACT

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

Refusal History

DateProductViolationsDivision
2/29/2012
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
235NOT IMPACT
New Orleans District Office (NOL-DO)
2/29/2012
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
235NOT IMPACT
New Orleans District Office (NOL-DO)
2/29/2012
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
235NOT IMPACT
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Dongguan Hamwell Glasses Co's FDA import refusal history?

Dongguan Hamwell Glasses Co (FEI: 1000648085) has 3 FDA import refusal record(s) in our database, spanning from 2/29/2012 to 2/29/2012.

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. Dongguan Hamwell Glasses Co's FEI number is 1000648085.

What types of violations has Dongguan Hamwell Glasses Co received?

Dongguan Hamwell Glasses 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 Dongguan Hamwell Glasses Co come from?

All FDA import refusal data for Dongguan Hamwell Glasses 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.