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Fukui Koki Co., Ltd

⚠️ Moderate Risk

FEI: 1000272341 • Sabae, Fukui • JAPAN

FEI

FEI Number

1000272341

📍

Location

Sabae, Fukui

🇯🇵

Country

JAPAN
🏢

Address

1-1-40, Sanroku-Cho, , Sabae, Fukui, Japan

Moderate Risk

FDA Import Risk Assessment

33.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
2/21/2003
Latest Refusal
2/20/2003
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

2312×

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.

2351×

NOT IMPACT

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

Refusal History

DateProductViolationsDivision
2/21/2003
86HQZFRAME, SPECTACLE
231LENS CERT
Seattle District Office (SEA-DO)
2/21/2003
86HQZFRAME, SPECTACLE
231LENS CERT
Seattle District Office (SEA-DO)
2/20/2003
86HQZFRAME, SPECTACLE
235NOT IMPACT
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Fukui Koki Co., Ltd's FDA import refusal history?

Fukui Koki Co., Ltd (FEI: 1000272341) has 3 FDA import refusal record(s) in our database, spanning from 2/20/2003 to 2/21/2003.

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. Fukui Koki Co., Ltd's FEI number is 1000272341.

What types of violations has Fukui Koki Co., Ltd received?

Fukui Koki 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 Fukui Koki Co., Ltd come from?

All FDA import refusal data for Fukui Koki 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.