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Hitachi Business International,Ltd.

⚠️ Moderate Risk

FEI: 3003823198 • Tokyo • JAPAN

FEI

FEI Number

3003823198

📍

Location

Tokyo

🇯🇵

Country

JAPAN
🏢

Address

6 Chome 655, Mihashi; Nishi, Tokyo, , Japan

Moderate Risk

FDA Import Risk Assessment

25.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
1/29/2018
Latest Refusal
1/29/2018
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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

4713×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

Refusal History

DateProductViolationsDivision
1/29/2018
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Division of Southwest Imports (DSWI)
1/29/2018
53LD06MOISTURIZING (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Division of Southwest Imports (DSWI)
1/29/2018
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is Hitachi Business International,Ltd.'s FDA import refusal history?

Hitachi Business International,Ltd. (FEI: 3003823198) has 3 FDA import refusal record(s) in our database, spanning from 1/29/2018 to 1/29/2018.

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 Business International,Ltd.'s FEI number is 3003823198.

What types of violations has Hitachi Business International,Ltd. received?

Hitachi Business International,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 Business International,Ltd. come from?

All FDA import refusal data for Hitachi Business International,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.