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Ruey Sheyng Glasses Ind. Co., Ltd.

⚠️ Moderate Risk

FEI: 1000262868 • Yeong-Kang, Hsian Tainan • TAIWAN

FEI

FEI Number

1000262868

📍

Location

Yeong-Kang, Hsian Tainan

🇹🇼

Country

TAIWAN
🏢

Address

403-2 Jong-Jeng Rd, , Yeong-Kang, Hsian Tainan, Taiwan

Moderate Risk

FDA Import Risk Assessment

27.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
10/13/2009
Latest Refusal
6/25/2009
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1182×

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
10/13/2009
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
San Francisco District Office (SAN-DO)
6/25/2009
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Ruey Sheyng Glasses Ind. Co., Ltd.'s FDA import refusal history?

Ruey Sheyng Glasses Ind. Co., Ltd. (FEI: 1000262868) has 2 FDA import refusal record(s) in our database, spanning from 6/25/2009 to 10/13/2009.

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. Ruey Sheyng Glasses Ind. Co., Ltd.'s FEI number is 1000262868.

What types of violations has Ruey Sheyng Glasses Ind. Co., Ltd. received?

Ruey Sheyng Glasses Ind. Co., 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 Ruey Sheyng Glasses Ind. Co., Ltd. come from?

All FDA import refusal data for Ruey Sheyng Glasses Ind. 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.