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MARUGEN CO.,LTD.

⚠️ Moderate Risk

FEI: 3004259595 • Ohnogun, Gifu • JAPAN

FEI

FEI Number

3004259595

📍

Location

Ohnogun, Gifu

🇯🇵

Country

JAPAN
🏢

Address

Nakata,Kata Aza,Kawamura-Cho,Tansho, , Ohnogun, Gifu, Japan

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/10/2002
Latest Refusal
9/10/2002
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

111×

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).

Refusal History

DateProductViolationsDivision
9/10/2002
33EGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

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

MARUGEN CO.,LTD. (FEI: 3004259595) has 1 FDA import refusal record(s) in our database, spanning from 9/10/2002 to 9/10/2002.

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. MARUGEN CO.,LTD.'s FEI number is 3004259595.

What types of violations has MARUGEN CO.,LTD. received?

MARUGEN CO.,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 MARUGEN CO.,LTD. come from?

All FDA import refusal data for MARUGEN 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.