Sti Laser Industries Ltd
⚠️ Moderate Risk
FEI: 3009874002 • Or Akiva • ISRAEL
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/17/2016 | 74PKKSTENT DELIVERY SYSTEM | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 11/30/2016 | 74NIVCORONARY COVERED STENT | New Orleans District Office (NOL-DO) | |
| 11/30/2016 | 74MAFSTENT, CARDIOVASCULAR | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sti Laser Industries Ltd's FDA import refusal history?
Sti Laser Industries Ltd (FEI: 3009874002) has 3 FDA import refusal record(s) in our database, spanning from 11/30/2016 to 12/17/2016.
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. Sti Laser Industries Ltd's FEI number is 3009874002.
What types of violations has Sti Laser Industries Ltd received?
Sti Laser Industries Ltd has been cited for 2 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 Sti Laser Industries Ltd come from?
All FDA import refusal data for Sti Laser Industries 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.