Nextar Chempharma Solutions, Ltd.
⚠️ High Risk
FEI: 3009141810 • Ness Ziona • ISRAEL
FEI Number
3009141810
Location
Ness Ziona
Country
ISRAELAddress
Einstein St., Building 13b, Weizmann Science Park, Ness Ziona, , 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
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).
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 |
|---|---|---|---|
| 4/11/2022 | 62VAV99ANTI-VIRAL N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/7/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/19/2021 | 62HAY99ANTI-MICROBIAL N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/26/2021 | 65RCV19SODIUM CHLORIDE (REPLENISHER) | Division of Southeast Imports (DSEI) | |
| 10/18/2021 | 61RBP08SODIUM NITRITE (ANTIDOTE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/13/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/12/2021 | 61RBP08SODIUM NITRITE (ANTIDOTE) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 10/8/2021 | 61RCV08SODIUM NITRITE (ANTIDOTE) | Division of Southeast Imports (DSEI) | |
| 10/8/2021 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 10/8/2021 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 10/8/2021 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 10/8/2021 | 64JCV02NITRIC OXIDE (MEDICINAL GAS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/4/2021 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/4/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Nextar Chempharma Solutions, Ltd.'s FDA import refusal history?
Nextar Chempharma Solutions, Ltd. (FEI: 3009141810) has 14 FDA import refusal record(s) in our database, spanning from 10/4/2021 to 4/11/2022.
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. Nextar Chempharma Solutions, Ltd.'s FEI number is 3009141810.
What types of violations has Nextar Chempharma Solutions, Ltd. received?
Nextar Chempharma Solutions, 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 Nextar Chempharma Solutions, Ltd. come from?
All FDA import refusal data for Nextar Chempharma Solutions, 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.