Shinkan Co., Ltd.
⚠️ Moderate Risk
FEI: 3003120012 • Kobe, Hyogo • JAPAN
FEI Number
3003120012
Location
Kobe, Hyogo
Country
JAPANAddress
2 Chome 1-1 Nakanoshima, Hyogo; Nakanoshima; Hyogo, Kobe, Hyogo, 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
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.
LACKS N/C
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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
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).
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 |
|---|---|---|---|
| 1/25/2006 | 37JGT99SAUCES, N.E.C. | San Francisco District Office (SAN-DO) | |
| 1/25/2006 | 24KGT20CUCUMBERS, WITH SAUCE | San Francisco District Office (SAN-DO) | |
| 12/16/2005 | 16AET33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 83NO PROCESS | San Francisco District Office (SAN-DO) |
| 6/10/2004 | 25JGT07RADISH (ROOT & TUBER VEGETABLE) | 11UNSAFE COL | San Francisco District Office (SAN-DO) |
| 5/26/2004 | 25JGT07RADISH (ROOT & TUBER VEGETABLE) | 64YELLOW #5 | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Shinkan Co., Ltd.'s FDA import refusal history?
Shinkan Co., Ltd. (FEI: 3003120012) has 5 FDA import refusal record(s) in our database, spanning from 5/26/2004 to 1/25/2006.
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. Shinkan Co., Ltd.'s FEI number is 3003120012.
What types of violations has Shinkan Co., Ltd. received?
Shinkan Co., Ltd. has been cited for 5 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 Shinkan Co., Ltd. come from?
All FDA import refusal data for Shinkan 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.