Eiwa Shoji Co. Ltd.
⚠️ Moderate Risk
FEI: 3002560512 • Tokyo • 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 ENGLISH
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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
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).
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
YELLOW #5
The food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 CFR 74.705(a)(c) under section 721.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/27/2009 | 25JGP07RADISH (ROOT & TUBER VEGETABLE) | 64YELLOW #5 | Los Angeles District Office (LOS-DO) |
| 2/6/2009 | 24AGP99BEANS, CORN, AND PEA, N.E.C. (VEGETABLE) | 324NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 2/6/2009 | 24AGP99BEANS, CORN, AND PEA, N.E.C. (VEGETABLE) | 324NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 2/6/2009 | 25JGP07RADISH (ROOT & TUBER VEGETABLE) | 324NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 2/6/2009 | 24TGP29SEAWEED (LEAF & STEM VEGETABLE) | 324NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 2/6/2009 | 24BGN13SOYBEANS (SEE INDUSTRY 37 FOR BEAN CURD), DRIED OR PASTE | 324NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 4/18/2008 | 25JGP24GINGER ROOT (ROOT & TUBER VEGETABLE) | 11UNSAFE COL | San Francisco District Office (SAN-DO) |
| 8/29/2007 | 25JGP07RADISH (ROOT & TUBER VEGETABLE) | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 11/17/2004 | 25YGP99VEGETABLE & VEGETABLE PRODUCTS NOT MENTIONED ELSEWHERE, N.E.C. | New York District Office (NYK-DO) | |
| 3/8/2004 | 25YCI99VEGETABLE & VEGETABLE PRODUCTS NOT MENTIONED ELSEWHERE, N.E.C. | 62NEEDS FCE | Chicago District Office (CHI-DO) |
| 3/8/2004 | 25YCI99VEGETABLE & VEGETABLE PRODUCTS NOT MENTIONED ELSEWHERE, N.E.C. | 62NEEDS FCE | Chicago District Office (CHI-DO) |
| 12/13/2002 | 16AGC79YELLOWTAIL, AMBERJACK | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Eiwa Shoji Co. Ltd.'s FDA import refusal history?
Eiwa Shoji Co. Ltd. (FEI: 3002560512) has 12 FDA import refusal record(s) in our database, spanning from 12/13/2002 to 3/27/2009.
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 Shoji Co. Ltd.'s FEI number is 3002560512.
What types of violations has Eiwa Shoji Co. Ltd. received?
Eiwa Shoji Co. Ltd. has been cited for 7 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 Shoji Co. Ltd. come from?
All FDA import refusal data for Eiwa Shoji 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.