KATOM QP LTD
⚠️ High Risk
FEI: 3020138890 • Ganei Tikva • ISRAEL
FEI Number
3020138890
Location
Ganei Tikva
Country
ISRAELAddress
36, Giv'On, , Ganei Tikva, , 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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/20/2024 | 66VIQ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 2/6/2023 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 2/6/2023 | 64JDQ02NITRIC OXIDE (MEDICINAL GAS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/2/2022 | 66VIL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 11/2/2021 | 64JBK02NITRIC OXIDE (MEDICINAL GAS) | Division of Southeast Imports (DSEI) | |
| 11/2/2021 | 64JBK02NITRIC OXIDE (MEDICINAL GAS) | Division of Southeast Imports (DSEI) | |
| 11/2/2021 | 64JBK02NITRIC OXIDE (MEDICINAL GAS) | Division of Southeast Imports (DSEI) | |
| 11/2/2021 | 65RBY19SODIUM CHLORIDE (REPLENISHER) | Division of Southeast Imports (DSEI) | |
| 11/2/2021 | 64JBK02NITRIC OXIDE (MEDICINAL GAS) | Division of Southeast Imports (DSEI) | |
| 10/26/2021 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 10/15/2021 | 62OCA18BISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/12/2021 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 10/12/2021 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 10/5/2021 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is KATOM QP LTD's FDA import refusal history?
KATOM QP LTD (FEI: 3020138890) has 14 FDA import refusal record(s) in our database, spanning from 10/5/2021 to 5/20/2024.
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. KATOM QP LTD's FEI number is 3020138890.
What types of violations has KATOM QP LTD received?
KATOM QP 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 KATOM QP LTD come from?
All FDA import refusal data for KATOM QP 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.