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Wah Ming Optical Mfy Ltd

⚠️ Moderate Risk

FEI: 3007335022 • Shenzhen, Guangdong • CHINA

FEI

FEI Number

3007335022

📍

Location

Shenzhen, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Ao Bei Ind 23, Hongling Bei Road East Ce, Shenzhen, Guangdong, 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
1
Unique Violations
11/5/2013
Latest Refusal
11/5/2013
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

1184×

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
11/5/2013
86HQZFRAME, SPECTACLE
118NOT LISTED
New Orleans District Office (NOL-DO)
11/5/2013
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
New Orleans District Office (NOL-DO)
11/5/2013
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
New Orleans District Office (NOL-DO)
11/5/2013
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Wah Ming Optical Mfy Ltd's FDA import refusal history?

Wah Ming Optical Mfy Ltd (FEI: 3007335022) has 4 FDA import refusal record(s) in our database, spanning from 11/5/2013 to 11/5/2013.

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. Wah Ming Optical Mfy Ltd's FEI number is 3007335022.

What types of violations has Wah Ming Optical Mfy Ltd received?

Wah Ming Optical Mfy 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 Wah Ming Optical Mfy Ltd come from?

All FDA import refusal data for Wah Ming Optical Mfy 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.