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Hitachi Ltd

⚠️ Moderate Risk

FEI: 1000165976 • Ba, Tokyo • JAPAN

FEI

FEI Number

1000165976

📍

Location

Ba, Tokyo

🇯🇵

Country

JAPAN
🏢

Address

2chome 15-12 2-Chome, Nishi-Shin, Ba, Tokyo, 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
6/2/2005
Latest Refusal
6/2/2005
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
6/2/2005
94V05CATHODE RAY TUBE
476NO REGISTR
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Hitachi Ltd's FDA import refusal history?

Hitachi Ltd (FEI: 1000165976) has 1 FDA import refusal record(s) in our database, spanning from 6/2/2005 to 6/2/2005.

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. Hitachi Ltd's FEI number is 1000165976.

What types of violations has Hitachi Ltd received?

Hitachi 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 Hitachi Ltd come from?

All FDA import refusal data for Hitachi 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.