BI-SO CO.,LTD
⚠️ Moderate Risk
FEI: 3014736346 • Shiojiri, Nagano • JAPAN
FEI Number
3014736346
Location
Shiojiri, Nagano
Country
JAPANAddress
1824-2, Oazahirookano-Mura, Shiojiri, Nagano, 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
TP NO PMTA
This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that FDA has found to be adulterated under section 902(6)(A) of the FD&C Act in that it does not have an FDA marketing order in effect under section 910(c)(1)(A)(i) of the FD&C Act.
TP NO SE
This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that FDA has found to be misbranded under section 903(a)(6) of the FD&C Act in that a notice or other information respecting it was not provided as required by section 905(j).
TPLACKFIRM
This article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(A) of the FD&C Act in that the label does not contain the name and place of business of the tobacco product manufacturer, packer or distributor.
TPLKUSSLLB
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(D) of the FD&C Act in that the label does not provide the statement "sale only allowed in the United States" and the tobacco product is not subject to any exemptions or variations.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/5/2024 | 98MCA01E-LIQUID | Division of West Coast Imports (DWCI) | |
| 1/5/2024 | 98MCA01E-LIQUID | Division of West Coast Imports (DWCI) | |
| 1/5/2024 | 98MCA01E-LIQUID | Division of West Coast Imports (DWCI) | |
| 1/5/2024 | 98MCA01E-LIQUID | Division of West Coast Imports (DWCI) | |
| 1/5/2024 | 98MBA01E-LIQUID | Division of West Coast Imports (DWCI) | |
| 1/5/2024 | 98MBA01E-LIQUID | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is BI-SO CO.,LTD's FDA import refusal history?
BI-SO CO.,LTD (FEI: 3014736346) has 6 FDA import refusal record(s) in our database, spanning from 1/5/2024 to 1/5/2024.
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. BI-SO CO.,LTD's FEI number is 3014736346.
What types of violations has BI-SO CO.,LTD received?
BI-SO CO.,LTD 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 BI-SO CO.,LTD come from?
All FDA import refusal data for BI-SO 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.