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Action Eyewear Co. Ltd.

⚠️ Moderate Risk

FEI: 3002720892 • Dongguan, Guangdong • CHINA

FEI

FEI Number

3002720892

📍

Location

Dongguan, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Chenwubeicun, Changping, Dongguan, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

31.2
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
11/19/2018
Latest Refusal
10/13/2009
Earliest Refusal

Score Breakdown

Violation Severity
57.5×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
4.4×10%
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

2313×

LENS CERT

The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.

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
11/19/2018
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
Division of Southeast Imports (DSEI)
10/13/2009
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
231LENS CERT
San Francisco District Office (SAN-DO)
10/13/2009
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
San Francisco District Office (SAN-DO)
10/13/2009
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Action Eyewear Co. Ltd.'s FDA import refusal history?

Action Eyewear Co. Ltd. (FEI: 3002720892) has 4 FDA import refusal record(s) in our database, spanning from 10/13/2009 to 11/19/2018.

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. Action Eyewear Co. Ltd.'s FEI number is 3002720892.

What types of violations has Action Eyewear Co. Ltd. received?

Action Eyewear Co. Ltd. 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 Action Eyewear Co. Ltd. come from?

All FDA import refusal data for Action Eyewear 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.