Inoue Company Ltd
⚠️ Moderate Risk
FEI: 3002304578 • Yamaguchi • 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).
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
LACKS FIRM
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/19/2003 | 02DGT99RICE, PROCESSED (PACKAGED) N.E.C. | Los Angeles District Office (LOS-DO) | |
| 2/11/2003 | 02DDN99RICE, PROCESSED (PACKAGED) N.E.C. | Los Angeles District Office (LOS-DO) | |
| 2/11/2003 | 02DDN99RICE, PROCESSED (PACKAGED) N.E.C. | Los Angeles District Office (LOS-DO) | |
| 5/6/2002 | 02DGT99RICE, PROCESSED (PACKAGED) N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Inoue Company Ltd's FDA import refusal history?
Inoue Company Ltd (FEI: 3002304578) has 4 FDA import refusal record(s) in our database, spanning from 5/6/2002 to 2/19/2003.
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. Inoue Company Ltd's FEI number is 3002304578.
What types of violations has Inoue Company Ltd received?
Inoue Company Ltd has been cited for 5 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 Inoue Company Ltd come from?
All FDA import refusal data for Inoue Company 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.