YAMANAKA KANZUME CO., LTD.
⚠️ High Risk
FEI: 3013050753 • Yaizu, Shizuoka • JAPAN
FEI Number
3013050753
Location
Yaizu, Shizuoka
Country
JAPANAddress
Sizuoka 466, Koyashiki, Yaizu, Shizuoka, 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
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/15/2025 | 31AEE99COFFEE, N.E.C. | Division of West Coast Imports (DWCI) | |
| 12/24/2014 | 31KET01TEA, BLACK | 83NO PROCESS | San Francisco District Office (SAN-DO) |
| 12/24/2014 | 31GET01COFFEE DRINK | 83NO PROCESS | San Francisco District Office (SAN-DO) |
| 12/24/2014 | 31GET01COFFEE DRINK | 83NO PROCESS | San Francisco District Office (SAN-DO) |
| 12/24/2014 | 31GET01COFFEE DRINK | 83NO PROCESS | San Francisco District Office (SAN-DO) |
| 12/24/2014 | 31GET01COFFEE DRINK | 83NO PROCESS | San Francisco District Office (SAN-DO) |
| 12/24/2014 | 31GET01COFFEE DRINK | 83NO PROCESS | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is YAMANAKA KANZUME CO., LTD.'s FDA import refusal history?
YAMANAKA KANZUME CO., LTD. (FEI: 3013050753) has 7 FDA import refusal record(s) in our database, spanning from 12/24/2014 to 4/15/2025.
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. YAMANAKA KANZUME CO., LTD.'s FEI number is 3013050753.
What types of violations has YAMANAKA KANZUME CO., LTD. received?
YAMANAKA KANZUME CO., LTD. has been cited for 2 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 YAMANAKA KANZUME CO., LTD. come from?
All FDA import refusal data for YAMANAKA KANZUME 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.