Itsuki Co Ltd
⚠️ Moderate Risk
FEI: 3001801329 • Kumamoto • JAPAN
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/20/2003 | 04CGT07NOODLES, INSTANT | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/20/2003 | 04CGT07NOODLES, INSTANT | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 7/21/2003 | 04CGT05NOODLES, WHEAT AND SOY | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 2/11/2003 | 04CGT07NOODLES, INSTANT | Los Angeles District Office (LOS-DO) | |
| 2/11/2003 | 04CGT07NOODLES, INSTANT | Los Angeles District Office (LOS-DO) | |
| 10/8/2002 | 04CGT07NOODLES, INSTANT | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 9/4/2002 | 04CGT07NOODLES, INSTANT | Los Angeles District Office (LOS-DO) | |
| 5/10/2002 | 04CGT07NOODLES, INSTANT | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Itsuki Co Ltd's FDA import refusal history?
Itsuki Co Ltd (FEI: 3001801329) has 8 FDA import refusal record(s) in our database, spanning from 5/10/2002 to 10/20/2003.
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. Itsuki Co Ltd's FEI number is 3001801329.
What types of violations has Itsuki Co Ltd received?
Itsuki 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 Itsuki Co Ltd come from?
All FDA import refusal data for Itsuki 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.