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MARUAI CO.,LTD. OSAKA BRANCH

⚠️ Moderate Risk

FEI: 3004301769 • Higashiosaka, Osaka • JAPAN

FEI

FEI Number

3004301769

📍

Location

Higashiosaka, Osaka

🇯🇵

Country

JAPAN
🏢

Address

1 Chome 15, Honjonaka, Higashiosaka, Osaka, Japan

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
6/8/2012
Latest Refusal
6/8/2012
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

3062×

INSANITARY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
6/8/2012
16AGH07BONITO
306INSANITARY
San Francisco District Office (SAN-DO)
6/8/2012
16AGH07BONITO
306INSANITARY
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is MARUAI CO.,LTD. OSAKA BRANCH's FDA import refusal history?

MARUAI CO.,LTD. OSAKA BRANCH (FEI: 3004301769) has 2 FDA import refusal record(s) in our database, spanning from 6/8/2012 to 6/8/2012.

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. MARUAI CO.,LTD. OSAKA BRANCH's FEI number is 3004301769.

What types of violations has MARUAI CO.,LTD. OSAKA BRANCH received?

MARUAI CO.,LTD. OSAKA BRANCH 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 MARUAI CO.,LTD. OSAKA BRANCH come from?

All FDA import refusal data for MARUAI CO.,LTD. OSAKA BRANCH 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.