Kurotani Shoten
⚠️ Moderate Risk
FEI: 3022264992 • Osaka, Osaka • JAPAN
FEI Number
3022264992
Location
Osaka, Osaka
Country
JAPANAddress
6 Chome 9-34, Tajima; Ikuno, 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
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
Frequently Asked Questions
What is Kurotani Shoten's FDA import refusal history?
Kurotani Shoten (FEI: 3022264992) has 1 FDA import refusal record(s) in our database, spanning from 6/14/2023 to 6/14/2023.
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. Kurotani Shoten's FEI number is 3022264992.
What types of violations has Kurotani Shoten received?
Kurotani Shoten has been cited for 4 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 Kurotani Shoten come from?
All FDA import refusal data for Kurotani Shoten 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.