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Ace International Japan Company Ltd

✅ Low Risk

FEI: 1000498141 • Minato, Tokyo • JAPAN

FEI

FEI Number

1000498141

📍

Location

Minato, Tokyo

🇯🇵

Country

JAPAN
🏢

Address

4 Chome 13-3, Shiba, Minato, Tokyo, Japan

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
9/3/2009
Latest Refusal
9/3/2009
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
9/3/2009
79FXXMASK, SURGICAL
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Ace International Japan Company Ltd's FDA import refusal history?

Ace International Japan Company Ltd (FEI: 1000498141) has 1 FDA import refusal record(s) in our database, spanning from 9/3/2009 to 9/3/2009.

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. Ace International Japan Company Ltd's FEI number is 1000498141.

What types of violations has Ace International Japan Company Ltd received?

Ace International Japan Company 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 Ace International Japan Company Ltd come from?

All FDA import refusal data for Ace International Japan Company 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.