Suzhou Sen Sen Medical Supplies Ltd
⚠️ Moderate Risk
FEI: 3009614471 • Suzhou • 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
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
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).
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 |
|---|---|---|---|
| 7/31/2013 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 479DV QUALITY | New York District Office (NYK-DO) |
| 7/31/2013 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 479DV QUALITY | New York District Office (NYK-DO) |
| 5/30/2013 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Suzhou Sen Sen Medical Supplies Ltd's FDA import refusal history?
Suzhou Sen Sen Medical Supplies Ltd (FEI: 3009614471) has 3 FDA import refusal record(s) in our database, spanning from 5/30/2013 to 7/31/2013.
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. Suzhou Sen Sen Medical Supplies Ltd's FEI number is 3009614471.
What types of violations has Suzhou Sen Sen Medical Supplies Ltd received?
Suzhou Sen Sen Medical Supplies 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 Suzhou Sen Sen Medical Supplies Ltd come from?
All FDA import refusal data for Suzhou Sen Sen Medical Supplies 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.