Kanebo Shokuhin Co., Ltd
⚠️ Moderate Risk
FEI: 3001657055 • Sumida, Tokyo • JAPAN
FEI Number
3001657055
Location
Sumida, Tokyo
Country
JAPANAddress
5 Chome 17-4, Sumida, Sumida, Tokyo, 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/22/2004 | 53EA02HAIR SPRAYS (AEROSOL FIXATIVES) (HAIR PREPARATIONS, NON-COLORING) | 251POISONOUS | Los Angeles District Office (LOS-DO) |
| 11/20/2003 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Kanebo Shokuhin Co., Ltd's FDA import refusal history?
Kanebo Shokuhin Co., Ltd (FEI: 3001657055) has 2 FDA import refusal record(s) in our database, spanning from 11/20/2003 to 12/22/2004.
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. Kanebo Shokuhin Co., Ltd's FEI number is 3001657055.
What types of violations has Kanebo Shokuhin Co., Ltd received?
Kanebo Shokuhin 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 Kanebo Shokuhin Co., Ltd come from?
All FDA import refusal data for Kanebo Shokuhin 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.