Marugen, Inc.
⚠️ High Risk
FEI: 3008915847 • Takayama, Gihu • JAPAN
FEI Number
3008915847
Location
Takayama, Gihu
Country
JAPANAddress
1377-5, Nyukawachomachikata, Takayama, Gihu, Japan
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
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
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).
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
YELLOW #5
The food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 CFR 74.705(a)(c) under section 721.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/12/2025 | 33EGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | Division of Northeast Imports (DNEI) | |
| 1/13/2025 | 33EGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 11UNSAFE COL | Division of Northeast Imports (DNEI) |
| 1/13/2025 | 33EGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 11UNSAFE COL | Division of Northeast Imports (DNEI) |
| 10/6/2022 | 33EGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 11UNSAFE COL | Division of Northern Border Imports (DNBI) |
| 6/5/2018 | 33EFT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | Division of West Coast Imports (DWCI) | |
| 11/4/2015 | 33EGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | Chicago District Office (CHI-DO) | |
| 8/10/2011 | 33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) | 11UNSAFE COL | New York District Office (NYK-DO) |
| 2/11/2010 | 33SGT06LOLLIPOP (WITHOUT CHOCOLATE) | 11UNSAFE COL | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Marugen, Inc.'s FDA import refusal history?
Marugen, Inc. (FEI: 3008915847) has 8 FDA import refusal record(s) in our database, spanning from 2/11/2010 to 3/12/2025.
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, Inc.'s FEI number is 3008915847.
What types of violations has Marugen, Inc. received?
Marugen, Inc. has been cited for 4 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, Inc. come from?
All FDA import refusal data for Marugen, Inc. 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.