Kawa Corporation
⚠️ Moderate Risk
FEI: 3003348025 • Kobe, Hyogo • JAPAN
FEI Number
3003348025
Location
Kobe, Hyogo
Country
JAPANAddress
2 Chome 8 Ogawadori, Hyogo; Ogawadori; Hyogo, Kobe, Hyogo, 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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/7/2002 | 80FQMBANDAGE, ELASTIC | Los Angeles District Office (LOS-DO) | |
| 6/7/2002 | 76JEQTOOTHBRUSH, POWERED | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 6/7/2002 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 5/23/2002 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 5/23/2002 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Kawa Corporation's FDA import refusal history?
Kawa Corporation (FEI: 3003348025) has 5 FDA import refusal record(s) in our database, spanning from 5/23/2002 to 6/7/2002.
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. Kawa Corporation's FEI number is 3003348025.
What types of violations has Kawa Corporation received?
Kawa Corporation 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 Kawa Corporation come from?
All FDA import refusal data for Kawa Corporation 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.