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Aisin Seiki Co Ltd

⚠️ Moderate Risk

FEI: 1000654303 • Kariya, Aichi • JAPAN

FEI

FEI Number

1000654303

📍

Location

Kariya, Aichi

🇯🇵

Country

JAPAN
🏢

Address

8 Chome 12, Hitotsugi-Cho, Kariya, Aichi, 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
6/24/2002
Latest Refusal
6/24/2002
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

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
6/24/2002
95L22LASER PRODUCT FOR NON-MEDICAL USE
476NO REGISTR
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Aisin Seiki Co Ltd's FDA import refusal history?

Aisin Seiki Co Ltd (FEI: 1000654303) has 1 FDA import refusal record(s) in our database, spanning from 6/24/2002 to 6/24/2002.

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. Aisin Seiki Co Ltd's FEI number is 1000654303.

What types of violations has Aisin Seiki Co Ltd received?

Aisin Seiki 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 Aisin Seiki Co Ltd come from?

All FDA import refusal data for Aisin Seiki 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.