Tsukezen Shoten Co., Ltd.
⚠️ Moderate Risk
FEI: 1000335713 • Osaka, Osaka • JAPAN
FEI Number
1000335713
Location
Osaka, Osaka
Country
JAPANAddress
3 Chome 32-8, Nakatsu; Kita, Osaka, Osaka, 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 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
Frequently Asked Questions
What is Tsukezen Shoten Co., Ltd.'s FDA import refusal history?
Tsukezen Shoten Co., Ltd. (FEI: 1000335713) has 3 FDA import refusal record(s) in our database, spanning from 2/7/2018 to 7/15/2022.
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. Tsukezen Shoten Co., Ltd.'s FEI number is 1000335713.
What types of violations has Tsukezen Shoten Co., Ltd. received?
Tsukezen Shoten 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 Tsukezen Shoten Co., Ltd. come from?
All FDA import refusal data for Tsukezen Shoten 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.