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Shine Wood Optical Manufactory Ltd.

⚠️ Moderate Risk

FEI: 3003052252 • Sha Tin, New Territories (N.T.) • HONG KONG

FEI

FEI Number

3003052252

📍

Location

Sha Tin, New Territories (N.T.)

🇭🇰

Country

HONG KONG
🏢

Address

Flat 15, 17/F., New Commerce Centre 19 On Sum Street,, , Sha Tin, New Territories (N.T.), Hong Kong

Moderate Risk

FDA Import Risk Assessment

31.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
11/20/2017
Latest Refusal
11/7/2017
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

2352×

NOT IMPACT

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

Refusal History

DateProductViolationsDivision
11/20/2017
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
Division of Northern Border Imports (DNBI)
11/7/2017
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Shine Wood Optical Manufactory Ltd.'s FDA import refusal history?

Shine Wood Optical Manufactory Ltd. (FEI: 3003052252) has 2 FDA import refusal record(s) in our database, spanning from 11/7/2017 to 11/20/2017.

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. Shine Wood Optical Manufactory Ltd.'s FEI number is 3003052252.

What types of violations has Shine Wood Optical Manufactory Ltd. received?

Shine Wood Optical Manufactory 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 Shine Wood Optical Manufactory Ltd. come from?

All FDA import refusal data for Shine Wood Optical Manufactory 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.