SHOKU EN co.,ltd
⚠️ Moderate Risk
FEI: 3012130094 • Shingu, Wakayama • JAPAN
FEI Number
3012130094
Location
Shingu, Wakayama
Country
JAPANAddress
Shingu 2122-3, Sano, Shingu, Wakayama, 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
MFRHACCP
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health in that it appears to have been processed in violation of 21 CFR 123.6(a) and 123.8(a).
INSANITARY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/6/2020 | 16XVC99AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS, N.E.C., | Division of Northeast Imports (DNEI) | |
| 3/6/2020 | 16XVC99AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS, N.E.C., | Division of Northeast Imports (DNEI) | |
| 3/6/2020 | 16XVC99AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS, N.E.C., | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is SHOKU EN co.,ltd's FDA import refusal history?
SHOKU EN co.,ltd (FEI: 3012130094) has 3 FDA import refusal record(s) in our database, spanning from 3/6/2020 to 3/6/2020.
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. SHOKU EN co.,ltd's FEI number is 3012130094.
What types of violations has SHOKU EN co.,ltd received?
SHOKU EN 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 SHOKU EN co.,ltd come from?
All FDA import refusal data for SHOKU EN 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.