SMARTRANS INTERNATIONAL LTD
⚠️ Moderate Risk
FEI: 3016903390 • Shenzhen • CHINA
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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/9/2020 | 73CBKVENTILATOR, CONTINUOUS (RESPIRATOR) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 12/9/2020 | 73CBKVENTILATOR, CONTINUOUS (RESPIRATOR) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 12/9/2020 | 73CBKVENTILATOR, CONTINUOUS (RESPIRATOR) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 12/9/2020 | 73CBKVENTILATOR, CONTINUOUS (RESPIRATOR) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is SMARTRANS INTERNATIONAL LTD's FDA import refusal history?
SMARTRANS INTERNATIONAL LTD (FEI: 3016903390) has 4 FDA import refusal record(s) in our database, spanning from 12/9/2020 to 12/9/2020.
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. SMARTRANS INTERNATIONAL LTD's FEI number is 3016903390.
What types of violations has SMARTRANS INTERNATIONAL LTD received?
SMARTRANS INTERNATIONAL LTD has been cited for 1 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 SMARTRANS INTERNATIONAL LTD come from?
All FDA import refusal data for SMARTRANS 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.