OGURAYA KONBU
⚠️ Moderate Risk
FEI: 3012945263 • Hirakata, Osaka • JAPAN
FEI Number
3012945263
Location
Hirakata, Osaka
Country
JAPANAddress
3 Chome 9, Shodaitajika, Hirakata, Osaka, 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.
LIST INGRE
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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/16/2004 | 24TVN29SEAWEED (LEAF & STEM VEGETABLE) | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 6/16/2004 | 24TVN29SEAWEED (LEAF & STEM VEGETABLE) | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 6/1/2004 | 24BVF08LIMA BEAN, DRIED OR PASTE | Los Angeles District Office (LOS-DO) | |
| 9/6/2002 | 25HGT99MIXED VEGETABLES, WITH SAUCE, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 9/6/2002 | 25HGT99MIXED VEGETABLES, WITH SAUCE, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 9/6/2002 | 25HGT99MIXED VEGETABLES, WITH SAUCE, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 9/6/2002 | 25HGT99MIXED VEGETABLES, WITH SAUCE, N.E.C. | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is OGURAYA KONBU's FDA import refusal history?
OGURAYA KONBU (FEI: 3012945263) has 7 FDA import refusal record(s) in our database, spanning from 9/6/2002 to 6/16/2004.
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. OGURAYA KONBU's FEI number is 3012945263.
What types of violations has OGURAYA KONBU received?
OGURAYA KONBU 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 OGURAYA KONBU come from?
All FDA import refusal data for OGURAYA KONBU 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.