Mizkan Co.,Ltd. TOCHIGI PLANT
⚠️ Moderate Risk
FEI: 3001163600 • Tochigi, Tochigi • JAPAN
FEI Number
3001163600
Location
Tochigi, Tochigi
Country
JAPANAddress
2436, Otsuka-Machi, Tochigi, Tochigi, 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
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.
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 |
|---|---|---|---|
| 8/9/2013 | 37JCE05SOY SAUCE | 274COLOR LBLG | Los Angeles District Office (LOS-DO) |
| 8/9/2013 | 37JCT05SOY SAUCE | 260FALSE | Los Angeles District Office (LOS-DO) |
| 8/9/2013 | 37JCT05SOY SAUCE | 260FALSE | Los Angeles District Office (LOS-DO) |
| 8/9/2013 | 37JCT05SOY SAUCE | 260FALSE | Los Angeles District Office (LOS-DO) |
| 8/9/2013 | 37JGT05SOY SAUCE | 260FALSE | Los Angeles District Office (LOS-DO) |
| 8/9/2013 | 37JGT05SOY SAUCE | 260FALSE | Los Angeles District Office (LOS-DO) |
| 2/22/2011 | 37JHT05SOY SAUCE | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Mizkan Co.,Ltd. TOCHIGI PLANT's FDA import refusal history?
Mizkan Co.,Ltd. TOCHIGI PLANT (FEI: 3001163600) has 7 FDA import refusal record(s) in our database, spanning from 2/22/2011 to 8/9/2013.
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. Mizkan Co.,Ltd. TOCHIGI PLANT's FEI number is 3001163600.
What types of violations has Mizkan Co.,Ltd. TOCHIGI PLANT received?
Mizkan Co.,Ltd. TOCHIGI PLANT 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 Mizkan Co.,Ltd. TOCHIGI PLANT come from?
All FDA import refusal data for Mizkan Co.,Ltd. TOCHIGI PLANT 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.