FURUKAWA ELECTRIC ADVANCED ENGINEERING CO.,LTD.
⚠️ Moderate Risk
FEI: 3000287971 • Ichihara, Chiba • JAPAN
FEI Number
3000287971
Location
Ichihara, Chiba
Country
JAPANAddress
6,YAWATA-KAIGANDORI, , Ichihara, Chiba, 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
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
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).
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).
Refusal History
Frequently Asked Questions
What is FURUKAWA ELECTRIC ADVANCED ENGINEERING CO.,LTD.'s FDA import refusal history?
FURUKAWA ELECTRIC ADVANCED ENGINEERING CO.,LTD. (FEI: 3000287971) has 3 FDA import refusal record(s) in our database, spanning from 5/10/2005 to 1/11/2024.
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. FURUKAWA ELECTRIC ADVANCED ENGINEERING CO.,LTD.'s FEI number is 3000287971.
What types of violations has FURUKAWA ELECTRIC ADVANCED ENGINEERING CO.,LTD. received?
FURUKAWA ELECTRIC ADVANCED ENGINEERING CO.,LTD. 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 FURUKAWA ELECTRIC ADVANCED ENGINEERING CO.,LTD. come from?
All FDA import refusal data for FURUKAWA ELECTRIC ADVANCED ENGINEERING 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.