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Kawasaki Heavy Industries Ltd

⚠️ Moderate Risk

FEI: 3000939034 • Kobe • JAPAN

FEI

FEI Number

3000939034

📍

Location

Kobe

🇯🇵

Country

JAPAN
🏢

Address

1-1 Higashikawaski-Cho 3-Chome, , Kobe, , Japan

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
2/14/2005
Latest Refusal
2/14/2005
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

162×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
2/14/2005
61HBL99ANTI-BACTERIAL, N.E.C.
16DIRECTIONS
New Orleans District Office (NOL-DO)
2/14/2005
62UBY99ANTI-TUSSIVE/COLD N.E.C.
16DIRECTIONS
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Kawasaki Heavy Industries Ltd's FDA import refusal history?

Kawasaki Heavy Industries Ltd (FEI: 3000939034) has 2 FDA import refusal record(s) in our database, spanning from 2/14/2005 to 2/14/2005.

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. Kawasaki Heavy Industries Ltd's FEI number is 3000939034.

What types of violations has Kawasaki Heavy Industries Ltd received?

Kawasaki Heavy Industries 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 Kawasaki Heavy Industries Ltd come from?

All FDA import refusal data for Kawasaki Heavy Industries 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.