Tradis Gat Ltd.
⚠️ High Risk
FEI: 3003035984 • Petach Tikvah • ISRAEL
FEI Number
3003035984
Location
Petach Tikvah
Country
ISRAELAddress
32 Hashacham St., , Petach Tikvah, , 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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/11/2023 | 61XDK49AZELASTINE, ANTI-HISTAMINE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/20/2022 | 62VDQ99ANTI-VIRAL N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/20/2022 | 62VDQ99ANTI-VIRAL N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/20/2022 | 62VDQ99ANTI-VIRAL N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/8/2022 | 80QIYNASAL SPRAY, SYSTEMIC DELIVERY, CDER OR CBER LED | Division of Southeast Imports (DSEI) | |
| 9/8/2022 | 64JBQ02NITRIC OXIDE (MEDICINAL GAS) | Division of Southeast Imports (DSEI) | |
| 9/7/2022 | 66VIQ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 9/2/2022 | 65RBL19SODIUM CHLORIDE (REPLENISHER) | Division of Southeast Imports (DSEI) | |
| 9/2/2022 | 64JBY02NITRIC OXIDE (MEDICINAL GAS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/2/2022 | 65RBQ19SODIUM CHLORIDE (REPLENISHER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/2/2022 | 65RBY19SODIUM CHLORIDE (REPLENISHER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/1/2022 | 66VIQ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 9/1/2022 | 66VIQ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 9/1/2022 | 66VIQ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 9/1/2022 | 66VIQ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 8/30/2022 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/19/2022 | 80QIYNASAL SPRAY, SYSTEMIC DELIVERY, CDER OR CBER LED | Division of Southeast Imports (DSEI) | |
| 8/17/2022 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/17/2022 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/17/2022 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/17/2022 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/17/2022 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/17/2022 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/17/2022 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/17/2022 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/17/2022 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/17/2022 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/16/2022 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 8/16/2022 | 65RBY19SODIUM CHLORIDE (REPLENISHER) | Division of Southeast Imports (DSEI) | |
| 8/16/2022 | 65RBL19SODIUM CHLORIDE (REPLENISHER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/11/2022 | 65RBQ19SODIUM CHLORIDE (REPLENISHER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/10/2022 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 8/5/2022 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/15/2022 | 66VIQ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/14/2022 | 80QIYNASAL SPRAY, SYSTEMIC DELIVERY, CDER OR CBER LED | Division of Southeast Imports (DSEI) | |
| 7/5/2022 | 64JAV02NITRIC OXIDE (MEDICINAL GAS) | Division of Southeast Imports (DSEI) | |
| 7/5/2022 | 66VIQ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 6/28/2022 | 64JAL02NITRIC OXIDE (MEDICINAL GAS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/28/2022 | 64JAL02NITRIC OXIDE (MEDICINAL GAS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/27/2022 | 66VDQ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/22/2022 | 64JBL02NITRIC OXIDE (MEDICINAL GAS) | Division of Southeast Imports (DSEI) | |
| 6/2/2022 | 64JBQ02NITRIC OXIDE (MEDICINAL GAS) | Division of Southeast Imports (DSEI) | |
| 6/2/2022 | 64JAV02NITRIC OXIDE (MEDICINAL GAS) | Division of Southeast Imports (DSEI) | |
| 6/2/2022 | 64JAV02NITRIC OXIDE (MEDICINAL GAS) | Division of Southeast Imports (DSEI) | |
| 9/13/2021 | 64JBY02NITRIC OXIDE (MEDICINAL GAS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Tradis Gat Ltd.'s FDA import refusal history?
Tradis Gat Ltd. (FEI: 3003035984) has 45 FDA import refusal record(s) in our database, spanning from 9/13/2021 to 4/11/2023.
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. Tradis Gat Ltd.'s FEI number is 3003035984.
What types of violations has Tradis Gat Ltd. received?
Tradis Gat Ltd. has been cited for 3 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 Tradis Gat Ltd. come from?
All FDA import refusal data for Tradis Gat 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.