ICHIBAN SHOKUHIN CO., LTD.
⚠️ Moderate Risk
FEI: 3004264682 • Omitama, Ibaraki • JAPAN
FEI Number
3004264682
Location
Omitama, Ibaraki
Country
JAPANAddress
748-1, Shibataka, Omitama, Ibaraki, 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
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).
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 |
|---|---|---|---|
| 6/11/2014 | 33LGT07JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 6/11/2014 | 37JCT02BARBECUE SAUCE | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 6/11/2014 | 27AGT03SALAD DRESSING, STANDARDIZED | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 6/11/2014 | 27AGT03SALAD DRESSING, STANDARDIZED | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 2/8/2010 | 37JHT99SAUCES, N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is ICHIBAN SHOKUHIN CO., LTD.'s FDA import refusal history?
ICHIBAN SHOKUHIN CO., LTD. (FEI: 3004264682) has 5 FDA import refusal record(s) in our database, spanning from 2/8/2010 to 6/11/2014.
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. ICHIBAN SHOKUHIN CO., LTD.'s FEI number is 3004264682.
What types of violations has ICHIBAN SHOKUHIN CO., LTD. received?
ICHIBAN SHOKUHIN 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 ICHIBAN SHOKUHIN CO., LTD. come from?
All FDA import refusal data for ICHIBAN SHOKUHIN 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.