Eiwa Holdings Co Ltd.
⚠️ High Risk
FEI: 3003405706 • Tokyo • 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
MFR INSAN
The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
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 |
|---|---|---|---|
| 8/17/2003 | 24TFE29SEAWEED (LEAF & STEM VEGETABLE) | New York District Office (NYK-DO) | |
| 6/12/2003 | 16AVC79YELLOWTAIL, AMBERJACK | 308MFR INSAN | Southwest Import District Office (SWI-DO) |
| 5/30/2003 | 16AVC79YELLOWTAIL, AMBERJACK | 308MFR INSAN | Division of Southwest Imports (DSWI) |
| 5/30/2003 | 16AVC79YELLOWTAIL, AMBERJACK | 308MFR INSAN | Division of Southwest Imports (DSWI) |
| 5/21/2003 | 16AVC79YELLOWTAIL, AMBERJACK | 308MFR INSAN | Southwest Import District Office (SWI-DO) |
| 5/21/2003 | 16AVC79YELLOWTAIL, AMBERJACK | 308MFR INSAN | Southwest Import District Office (SWI-DO) |
| 5/20/2003 | 16AVT79YELLOWTAIL, AMBERJACK | 308MFR INSAN | Southwest Import District Office (SWI-DO) |
| 5/20/2003 | 16AVC79YELLOWTAIL, AMBERJACK | 308MFR INSAN | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Eiwa Holdings Co Ltd.'s FDA import refusal history?
Eiwa Holdings Co Ltd. (FEI: 3003405706) has 8 FDA import refusal record(s) in our database, spanning from 5/20/2003 to 8/17/2003.
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. Eiwa Holdings Co Ltd.'s FEI number is 3003405706.
What types of violations has Eiwa Holdings Co Ltd. received?
Eiwa Holdings Co Ltd. 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 Eiwa Holdings Co Ltd. come from?
All FDA import refusal data for Eiwa Holdings 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.