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High Tech Optical Co.

⚠️ Moderate Risk

FEI: 3007108638 • Sabae, Fukui • JAPAN

FEI

FEI Number

3007108638

📍

Location

Sabae, Fukui

🇯🇵

Country

JAPAN
🏢

Address

3 Chome 403, Yanagi-Machi, Sabae, Fukui, Japan

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/26/2013
Latest Refusal
3/26/2013
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

2351×

NOT IMPACT

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

Refusal History

DateProductViolationsDivision
3/26/2013
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
New York District Office (NYK-DO)

Frequently Asked Questions

What is High Tech Optical Co.'s FDA import refusal history?

High Tech Optical Co. (FEI: 3007108638) has 1 FDA import refusal record(s) in our database, spanning from 3/26/2013 to 3/26/2013.

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. High Tech Optical Co.'s FEI number is 3007108638.

What types of violations has High Tech Optical Co. received?

High Tech Optical Co. 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 High Tech Optical Co. come from?

All FDA import refusal data for High Tech Optical Co. 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.