Kaneko Cord
⚠️ Moderate Risk
FEI: 3009748419 • Shizuoka • JAPAN
FEI Number
3009748419
Location
Shizuoka
Country
JAPANAddress
Hamamatsu Plant 80 Nakagawa, , 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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
DV NAME
The article appears to be a device and its labeling fails to bear the proprietary or established name.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/16/2012 | 86MSSFOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 11/16/2012 | 86MSSFOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 11/2/2012 | 86KYBLENS, GUIDE, INTRAOCULAR | New Orleans District Office (NOL-DO) | |
| 11/2/2012 | 86KYBLENS, GUIDE, INTRAOCULAR | New Orleans District Office (NOL-DO) | |
| 11/2/2012 | 86KYBLENS, GUIDE, INTRAOCULAR | New Orleans District Office (NOL-DO) | |
| 11/2/2012 | 86KYBLENS, GUIDE, INTRAOCULAR | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Kaneko Cord's FDA import refusal history?
Kaneko Cord (FEI: 3009748419) has 6 FDA import refusal record(s) in our database, spanning from 11/2/2012 to 11/16/2012.
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. Kaneko Cord's FEI number is 3009748419.
What types of violations has Kaneko Cord received?
Kaneko Cord 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 Kaneko Cord come from?
All FDA import refusal data for Kaneko Cord 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.