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Fujitsu Kasei Limited

⚠️ Moderate Risk

FEI: 3003356882 • Yokohama, Kanagawa • JAPAN

FEI

FEI Number

3003356882

📍

Location

Yokohama, Kanagawa

🇯🇵

Country

JAPAN
🏢

Address

1 Chome 11-11, Kitasaiwai; Nishi, Yokohama, Kanagawa, Japan

Moderate Risk

FDA Import Risk Assessment

34.5
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
4/7/2022
Latest Refusal
4/7/2022
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
10.7×20%
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

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
4/7/2022
95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
47NON STD
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Fujitsu Kasei Limited's FDA import refusal history?

Fujitsu Kasei Limited (FEI: 3003356882) has 1 FDA import refusal record(s) in our database, spanning from 4/7/2022 to 4/7/2022.

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. Fujitsu Kasei Limited's FEI number is 3003356882.

What types of violations has Fujitsu Kasei Limited received?

Fujitsu Kasei Limited 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 Fujitsu Kasei Limited come from?

All FDA import refusal data for Fujitsu Kasei Limited 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.