Hanita Lenses
⚠️ Moderate Risk
FEI: 3002807144 • Kibbutz Hanita • ISRAEL
FEI Number
3002807144
Location
Kibbutz Hanita
Country
ISRAELAddress
Kibbutz Hanita, , Kibbutz Hanita, , 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
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/23/2016 | 86HQLLENS, INTRAOCULAR | New Orleans District Office (NOL-DO) | |
| 6/15/2012 | 86HNHRING, OPHTHALMIC (FLIERINGA) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/11/2012 | 86HQLLENS, INTRAOCULAR | New Orleans District Office (NOL-DO) | |
| 6/28/2005 | 86HQLLENS, INTRAOCULAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 10/28/2004 | 86HQLLENS, INTRAOCULAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/12/2003 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 237NO PMA | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Hanita Lenses's FDA import refusal history?
Hanita Lenses (FEI: 3002807144) has 6 FDA import refusal record(s) in our database, spanning from 1/12/2003 to 12/23/2016.
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. Hanita Lenses's FEI number is 3002807144.
What types of violations has Hanita Lenses received?
Hanita Lenses 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 Hanita Lenses come from?
All FDA import refusal data for Hanita Lenses 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.