MARS SU
⚠️ Moderate Risk
FEI: 3018772124 • Shenzhen • CHINA
FEI Number
3018772124
Location
Shenzhen
Country
CHINAAddress
Buildingbno 55 Pingxinn, , 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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/31/2021 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 8/31/2021 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 8/31/2021 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 8/31/2021 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 8/31/2021 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 8/31/2021 | 86MVNLENS, CONTACT (DISPOSABLE) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 7/21/2021 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 7/21/2021 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 7/21/2021 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 7/21/2021 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is MARS SU's FDA import refusal history?
MARS SU (FEI: 3018772124) has 10 FDA import refusal record(s) in our database, spanning from 7/21/2021 to 8/31/2021.
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. MARS SU's FEI number is 3018772124.
What types of violations has MARS SU received?
MARS SU 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 MARS SU come from?
All FDA import refusal data for MARS SU 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.