ST INTERNATIONAL LTD
⚠️ Moderate Risk
FEI: 3023773207 • Kiriat Matalon • ISRAEL
FEI Number
3023773207
Location
Kiriat Matalon
Country
ISRAELAddress
14, Haodem St, , Kiriat Matalon, , 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
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/7/2022 | 86HLMINSTRUMENT, MEASURING, LENS, AC-POWERED | Division of Southeast Imports (DSEI) | |
| 11/7/2022 | 86HLMINSTRUMENT, MEASURING, LENS, AC-POWERED | Division of Southeast Imports (DSEI) | |
| 11/7/2022 | 86HLMINSTRUMENT, MEASURING, LENS, AC-POWERED | Division of Southeast Imports (DSEI) | |
| 11/7/2022 | 86HLMINSTRUMENT, MEASURING, LENS, AC-POWERED | Division of Southeast Imports (DSEI) | |
| 11/7/2022 | 86HLMINSTRUMENT, MEASURING, LENS, AC-POWERED | Division of Southeast Imports (DSEI) | |
| 11/7/2022 | 86HLMINSTRUMENT, MEASURING, LENS, AC-POWERED | Division of Southeast Imports (DSEI) | |
| 11/7/2022 | 86HLMINSTRUMENT, MEASURING, LENS, AC-POWERED | Division of Southeast Imports (DSEI) | |
| 11/7/2022 | 86HQZFRAME, SPECTACLE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ST INTERNATIONAL LTD's FDA import refusal history?
ST INTERNATIONAL LTD (FEI: 3023773207) has 8 FDA import refusal record(s) in our database, spanning from 11/7/2022 to 11/7/2022.
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. ST INTERNATIONAL LTD's FEI number is 3023773207.
What types of violations has ST INTERNATIONAL LTD received?
ST INTERNATIONAL 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 ST INTERNATIONAL LTD come from?
All FDA import refusal data for ST INTERNATIONAL 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.