KAO USA Inc
⚠️ Moderate Risk
FEI: 1513606 • Cincinnati, OH • UNITED STATES
FEI Number
1513606
Location
Cincinnati, OH
Country
UNITED STATESAddress
2535 Spring Grove Ave, , Cincinnati, OH, United States
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/4/2008 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 9/20/2006 | 62WAY17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/20/2006 | 62WAY17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/20/2006 | 62WAY17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is KAO USA Inc's FDA import refusal history?
KAO USA Inc (FEI: 1513606) has 4 FDA import refusal record(s) in our database, spanning from 9/20/2006 to 6/4/2008.
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. KAO USA Inc's FEI number is 1513606.
What types of violations has KAO USA Inc received?
KAO USA Inc has been cited for 3 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 KAO USA Inc come from?
All FDA import refusal data for KAO USA Inc 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.