Kracie Home Products Ltd
⚠️ High Risk
FEI: 3006346339 • Minato, Tokyo • JAPAN
FEI Number
3006346339
Location
Minato, Tokyo
Country
JAPANAddress
20-20-3, Kaigan, Minato, Tokyo, Japan
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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 |
|---|---|---|---|
| 2/10/2025 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 12/29/2014 | 53LF08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 12/10/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 1/27/2010 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 1/27/2010 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 1/27/2010 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 1/27/2010 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 1/27/2010 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 1/27/2010 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 1/27/2010 | 53LY09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 1/27/2010 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Kracie Home Products Ltd's FDA import refusal history?
Kracie Home Products Ltd (FEI: 3006346339) has 11 FDA import refusal record(s) in our database, spanning from 1/27/2010 to 2/10/2025.
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. Kracie Home Products Ltd's FEI number is 3006346339.
What types of violations has Kracie Home Products Ltd received?
Kracie Home Products Ltd has been cited for 5 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 Kracie Home Products Ltd come from?
All FDA import refusal data for Kracie Home Products 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.