Kujira Co Ltd
⚠️ Moderate Risk
FEI: 3004121692 • Shizuoka, Shizuoka • JAPAN
FEI Number
3004121692
Location
Shizuoka, Shizuoka
Country
JAPANAddress
1 Chome 16-16, Toro; Suruga, Shizuoka, Shizuoka, 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).
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.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/17/2004 | 80LDQDEVICE, GENERAL MEDICAL | Seattle District Office (SEA-DO) | |
| 8/19/2003 | 80LDQDEVICE, GENERAL MEDICAL | 118NOT LISTED | Seattle District Office (SEA-DO) |
| 3/31/2003 | 89NEBDEVICE, SPARK GAP, ENERGY WAVE FOR PAIN RELIEF | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Kujira Co Ltd's FDA import refusal history?
Kujira Co Ltd (FEI: 3004121692) has 3 FDA import refusal record(s) in our database, spanning from 3/31/2003 to 3/17/2004.
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. Kujira Co Ltd's FEI number is 3004121692.
What types of violations has Kujira Co Ltd received?
Kujira 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 Kujira Co Ltd come from?
All FDA import refusal data for Kujira 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.