Sion Biotext Medical Ltd.
⚠️ Moderate Risk
FEI: 3006118668 • Sderot • ISRAEL
FEI Number
3006118668
Location
Sderot
Country
ISRAELAddress
Sapirim Industrial Park, 3 Eshel Street, Sderot, , 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
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/12/2024 | 62FBK34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | Division of Southwest Imports (DSWI) | |
| 3/3/2017 | 60QBJ99ANESTHETIC, N.E.C. | Division of Northeast Imports (DNEI) | |
| 3/3/2017 | 60QBJ99ANESTHETIC, N.E.C. | Division of Northeast Imports (DNEI) | |
| 3/3/2017 | 60QBJ99ANESTHETIC, N.E.C. | Division of Northeast Imports (DNEI) | |
| 3/3/2017 | 60QBJ99ANESTHETIC, N.E.C. | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Sion Biotext Medical Ltd.'s FDA import refusal history?
Sion Biotext Medical Ltd. (FEI: 3006118668) has 5 FDA import refusal record(s) in our database, spanning from 3/3/2017 to 1/12/2024.
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. Sion Biotext Medical Ltd.'s FEI number is 3006118668.
What types of violations has Sion Biotext Medical Ltd. received?
Sion Biotext Medical 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 Sion Biotext Medical Ltd. come from?
All FDA import refusal data for Sion Biotext Medical 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.