Kimura Tsukemono Co.,Ltd.
⚠️ Moderate Risk
FEI: 3004308377 • Tahara, Aichi • JAPAN
FEI Number
3004308377
Location
Tahara, Aichi
Country
JAPANAddress
Uenodanshita 15, Takaki-Cho, Tahara, Aichi, 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
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.
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.
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).
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/7/2009 | 25JGT07RADISH (ROOT & TUBER VEGETABLE) | 64YELLOW #5 | Atlanta District Office (ATL-DO) |
| 1/22/2009 | 25JGT07RADISH (ROOT & TUBER VEGETABLE) | 260FALSE | San Francisco District Office (SAN-DO) |
| 8/15/2007 | 25NGT07RADISH, WITH SAUCE | New York District Office (NYK-DO) | |
| 11/16/2004 | 25NGT07RADISH, WITH SAUCE | 64YELLOW #5 | New York District Office (NYK-DO) |
| 8/18/2003 | 25JGT07RADISH (ROOT & TUBER VEGETABLE) | 83NO PROCESS | San Francisco District Office (SAN-DO) |
| 12/31/2002 | 25JGP27WHITE RADISH (ROOT & TUBER VEGETABLE) | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Kimura Tsukemono Co.,Ltd.'s FDA import refusal history?
Kimura Tsukemono Co.,Ltd. (FEI: 3004308377) has 6 FDA import refusal record(s) in our database, spanning from 12/31/2002 to 4/7/2009.
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. Kimura Tsukemono Co.,Ltd.'s FEI number is 3004308377.
What types of violations has Kimura Tsukemono Co.,Ltd. received?
Kimura Tsukemono 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 Kimura Tsukemono Co.,Ltd. come from?
All FDA import refusal data for Kimura Tsukemono 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.