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Maruto Seika Co., LTD

⚠️ Moderate Risk

FEI: 3004269156 • Fukuyama, Hiroshima • JAPAN

FEI

FEI Number

3004269156

📍

Location

Fukuyama, Hiroshima

🇯🇵

Country

JAPAN
🏢

Address

Nakatsuhara 1532, Miyuki-Cho, Fukuyama, Hiroshima, Japan

Moderate Risk

FDA Import Risk Assessment

38.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
11/23/2015
Latest Refusal
9/1/2015
Earliest Refusal

Score Breakdown

Violation Severity
77.5×40%
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

37012×

ALRGN402A4

it appears to be adulterated within the meaning of section 402(a)(4) because it appears that the food was prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health, specifically because the food appears to contain a major food allergen through insanitary conditions that led to cross-contact.

2181×

LIST INGRE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

33001×

ALLERGEN

the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).

Refusal History

DateProductViolationsDivision
11/23/2015
03RGT01CAKE WITHOUT CUSTARD OR CREAM FILLING
218LIST INGRE
3300ALLERGEN
3701ALRGN402A4
Division of Northeast Imports (DNEI)
9/1/2015
03RGT01CAKE WITHOUT CUSTARD OR CREAM FILLING
3701ALRGN402A4
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Maruto Seika Co., LTD's FDA import refusal history?

Maruto Seika Co., LTD (FEI: 3004269156) has 2 FDA import refusal record(s) in our database, spanning from 9/1/2015 to 11/23/2015.

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. Maruto Seika Co., LTD's FEI number is 3004269156.

What types of violations has Maruto Seika Co., LTD received?

Maruto Seika Co., LTD has been cited for 3 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 Maruto Seika Co., LTD come from?

All FDA import refusal data for Maruto Seika Co., 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.