Marukyo Co., Ltd.
⚠️ High Risk
FEI: 1000275076 • Yonago, Tottori • JAPAN
FEI Number
1000275076
Location
Yonago, Tottori
Country
JAPANAddress
2002-2, Hatagasaki, Yonago, Tottori, 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
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/25/2025 | 03RGT02CAKES, FILLED (OTHER THAN FRUIT OR JELLY) | 83NO PROCESS | Division of West Coast Imports (DWCI) |
| 10/28/2023 | 03RGT02CAKES, FILLED (OTHER THAN FRUIT OR JELLY) | 83NO PROCESS | Division of West Coast Imports (DWCI) |
| 10/28/2023 | 03RGT02CAKES, FILLED (OTHER THAN FRUIT OR JELLY) | 83NO PROCESS | Division of West Coast Imports (DWCI) |
| 4/20/2023 | 03RGT02CAKES, FILLED (OTHER THAN FRUIT OR JELLY) | 83NO PROCESS | Division of West Coast Imports (DWCI) |
| 4/20/2023 | 03RGT02CAKES, FILLED (OTHER THAN FRUIT OR JELLY) | 83NO PROCESS | Division of West Coast Imports (DWCI) |
| 4/20/2023 | 03RGT02CAKES, FILLED (OTHER THAN FRUIT OR JELLY) | 83NO PROCESS | Division of West Coast Imports (DWCI) |
| 3/24/2023 | 03RGT02CAKES, FILLED (OTHER THAN FRUIT OR JELLY) | 83NO PROCESS | Division of West Coast Imports (DWCI) |
| 3/24/2023 | 03RGT02CAKES, FILLED (OTHER THAN FRUIT OR JELLY) | 83NO PROCESS | Division of West Coast Imports (DWCI) |
| 3/21/2023 | 03RGT02CAKES, FILLED (OTHER THAN FRUIT OR JELLY) | 83NO PROCESS | Division of West Coast Imports (DWCI) |
| 3/21/2023 | 03RGT02CAKES, FILLED (OTHER THAN FRUIT OR JELLY) | 83NO PROCESS | Division of West Coast Imports (DWCI) |
| 3/10/2023 | 03RGT02CAKES, FILLED (OTHER THAN FRUIT OR JELLY) | 83NO PROCESS | Division of West Coast Imports (DWCI) |
| 3/10/2023 | 03RGT02CAKES, FILLED (OTHER THAN FRUIT OR JELLY) | 83NO PROCESS | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Marukyo Co., Ltd.'s FDA import refusal history?
Marukyo Co., Ltd. (FEI: 1000275076) has 12 FDA import refusal record(s) in our database, spanning from 3/10/2023 to 4/25/2025.
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. Marukyo Co., Ltd.'s FEI number is 1000275076.
What types of violations has Marukyo Co., Ltd. received?
Marukyo 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 Marukyo Co., Ltd. come from?
All FDA import refusal data for Marukyo 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.