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Billion Excel Optical Mfy. Co. L

⚠️ Moderate Risk

FEI: 3007024187 • Dong Guan • CHINA

FEI

FEI Number

3007024187

📍

Location

Dong Guan

🇨🇳

Country

CHINA
🏢

Address

Wo Long Zhen, , Feng Gang, Dong Guan, , China

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
6/20/2012
Latest Refusal
6/20/2012
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
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).

2351×

NOT IMPACT

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

Refusal History

DateProductViolationsDivision
6/20/2012
86HQZFRAME, SPECTACLE
118NOT LISTED
235NOT IMPACT
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Billion Excel Optical Mfy. Co. L's FDA import refusal history?

Billion Excel Optical Mfy. Co. L (FEI: 3007024187) has 1 FDA import refusal record(s) in our database, spanning from 6/20/2012 to 6/20/2012.

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. Billion Excel Optical Mfy. Co. L's FEI number is 3007024187.

What types of violations has Billion Excel Optical Mfy. Co. L received?

Billion Excel Optical Mfy. Co. L 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 Billion Excel Optical Mfy. Co. L come from?

All FDA import refusal data for Billion Excel Optical Mfy. Co. L 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.