KOHSEI FOODS
⚠️ High Risk
FEI: 3007499635 • Ibi-Gun, Gifu • JAPAN
FEI Number
3007499635
Location
Ibi-Gun, Gifu
Country
JAPANAddress
339-1, Oazakano; Ono-Cho, Ibi-Gun, Gifu, 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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/18/2023 | 29AGT99NONCARBONATED SOFT DRINK, N.E.C. | 83NO PROCESS | Division of West Coast Imports (DWCI) |
| 12/18/2023 | 29AGT99NONCARBONATED SOFT DRINK, N.E.C. | 83NO PROCESS | Division of West Coast Imports (DWCI) |
| 11/26/2021 | 29YGT99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C. | 83NO PROCESS | Division of Northeast Imports (DNEI) |
| 12/22/2020 | 29AGT99NONCARBONATED SOFT DRINK, N.E.C. | 83NO PROCESS | Division of West Coast Imports (DWCI) |
| 1/21/2020 | 29AGT99NONCARBONATED SOFT DRINK, N.E.C. | Division of West Coast Imports (DWCI) | |
| 12/20/2019 | 29AFT99NONCARBONATED SOFT DRINK, N.E.C. | 83NO PROCESS | Division of West Coast Imports (DWCI) |
| 7/11/2019 | 29AYT99NONCARBONATED SOFT DRINK, N.E.C. | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is KOHSEI FOODS's FDA import refusal history?
KOHSEI FOODS (FEI: 3007499635) has 7 FDA import refusal record(s) in our database, spanning from 7/11/2019 to 12/18/2023.
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. KOHSEI FOODS's FEI number is 3007499635.
What types of violations has KOHSEI FOODS received?
KOHSEI FOODS 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 KOHSEI FOODS come from?
All FDA import refusal data for KOHSEI FOODS 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.