EDWARDS LIFESCIENCES JAPAN LLC
⚠️ Moderate Risk
FEI: 3030534193 • Shinjuku, Tokyo • JAPAN
FEI Number
3030534193
Location
Shinjuku, Tokyo
Country
JAPANAddress
Kitashinjuku Shinjuku-Ku Tokyo, 2 Chome 21-1; Kitashinjuku, Shinjuku, Tokyo, 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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/2/2025 | 74LWRTISSUE, HEART-VALVE | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is EDWARDS LIFESCIENCES JAPAN LLC's FDA import refusal history?
EDWARDS LIFESCIENCES JAPAN LLC (FEI: 3030534193) has 1 FDA import refusal record(s) in our database, spanning from 5/2/2025 to 5/2/2025.
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. EDWARDS LIFESCIENCES JAPAN LLC's FEI number is 3030534193.
What types of violations has EDWARDS LIFESCIENCES JAPAN LLC received?
EDWARDS LIFESCIENCES JAPAN LLC has been cited for 1 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 EDWARDS LIFESCIENCES JAPAN LLC come from?
All FDA import refusal data for EDWARDS LIFESCIENCES JAPAN LLC 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.