NAVEH PHARMA (1966) LTD
⚠️ High Risk
FEI: 3027300316 • Netanya, Sharon area • ISRAEL
FEI Number
3027300316
Location
Netanya, Sharon area
Country
ISRAELAddress
11, Yad Kharutsim, , Netanya, Sharon area, 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
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).
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.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/17/2025 | 80KMJLUBRICANT, PATIENT | 3280FRNMFGREG | Division of Southwest Imports (DSWI) |
| 11/17/2025 | 62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL) | 118NOT LISTED | Division of Southwest Imports (DSWI) |
| 1/10/2025 | 65RBK19SODIUM CHLORIDE (REPLENISHER) | Division of Southeast Imports (DSEI) | |
| 11/14/2024 | 65RAK19SODIUM CHLORIDE (REPLENISHER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/9/2024 | 65RBY19SODIUM CHLORIDE (REPLENISHER) | Division of Southeast Imports (DSEI) | |
| 9/4/2024 | 65RBQ19SODIUM CHLORIDE (REPLENISHER) | Division of Southeast Imports (DSEI) | |
| 6/20/2023 | 65RAK19SODIUM CHLORIDE (REPLENISHER) | Division of Northern Border Imports (DNBI) | |
| 5/23/2012 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/14/2011 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is NAVEH PHARMA (1966) LTD's FDA import refusal history?
NAVEH PHARMA (1966) LTD (FEI: 3027300316) has 9 FDA import refusal record(s) in our database, spanning from 9/14/2011 to 11/17/2025.
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. NAVEH PHARMA (1966) LTD's FEI number is 3027300316.
What types of violations has NAVEH PHARMA (1966) LTD received?
NAVEH PHARMA (1966) LTD has been cited for 4 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 NAVEH PHARMA (1966) LTD come from?
All FDA import refusal data for NAVEH PHARMA (1966) 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.