FLEXTRONICS (ISRAEL) LTD
⚠️ High Risk
FEI: 3012535580 • Migdal Haemek • ISRAEL
FEI Number
3012535580
Location
Migdal Haemek
Country
ISRAELAddress
Ramat Gavriel Ind. Zone, 2, Hamatechet St, Migdal Haemek, , Israel
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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 PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/29/2025 | 74LPBCARDIAC ABLATION PERCUTANEOUS CATHETER | 2380NO PMA/PDP | Division of West Coast Imports (DWCI) |
| 5/29/2025 | 74LPBCARDIAC ABLATION PERCUTANEOUS CATHETER | 2380NO PMA/PDP | Division of West Coast Imports (DWCI) |
| 5/29/2025 | 74LPBCARDIAC ABLATION PERCUTANEOUS CATHETER | 2380NO PMA/PDP | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is FLEXTRONICS (ISRAEL) LTD's FDA import refusal history?
FLEXTRONICS (ISRAEL) LTD (FEI: 3012535580) has 3 FDA import refusal record(s) in our database, spanning from 5/29/2025 to 5/29/2025.
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. FLEXTRONICS (ISRAEL) LTD's FEI number is 3012535580.
What types of violations has FLEXTRONICS (ISRAEL) LTD received?
FLEXTRONICS (ISRAEL) LTD 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 FLEXTRONICS (ISRAEL) LTD come from?
All FDA import refusal data for FLEXTRONICS (ISRAEL) 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.