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MARUKO TSUKEMONO CO., LTD.

⚠️ Moderate Risk

FEI: 3012234673 • Niigata, Niigata • JAPAN

FEI

FEI Number

3012234673

📍

Location

Niigata, Niigata

🇯🇵

Country

JAPAN
🏢

Address

5609-2, Akatsuka; Nishi, Niigata, Niigata, Japan

Moderate Risk

FDA Import Risk Assessment

36.7
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
1/7/2021
Latest Refusal
5/15/2018
Earliest Refusal

Score Breakdown

Violation Severity
68.6×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
15.1×10%
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

114×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

2743×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

Refusal History

DateProductViolationsDivision
1/7/2021
25JGP07RADISH (ROOT & TUBER VEGETABLE)
11UNSAFE COL
274COLOR LBLG
Division of Northeast Imports (DNEI)
12/31/2020
25JGP07RADISH (ROOT & TUBER VEGETABLE)
11UNSAFE COL
274COLOR LBLG
Division of Northeast Imports (DNEI)
5/7/2020
25JGP07RADISH (ROOT & TUBER VEGETABLE)
11UNSAFE COL
274COLOR LBLG
Division of Northeast Imports (DNEI)
5/15/2018
25JGP07RADISH (ROOT & TUBER VEGETABLE)
11UNSAFE COL
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is MARUKO TSUKEMONO CO., LTD.'s FDA import refusal history?

MARUKO TSUKEMONO CO., LTD. (FEI: 3012234673) has 4 FDA import refusal record(s) in our database, spanning from 5/15/2018 to 1/7/2021.

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. MARUKO TSUKEMONO CO., LTD.'s FEI number is 3012234673.

What types of violations has MARUKO TSUKEMONO CO., LTD. received?

MARUKO TSUKEMONO CO., LTD. has been cited for 2 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 MARUKO TSUKEMONO CO., LTD. come from?

All FDA import refusal data for MARUKO TSUKEMONO 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.