Shenzhen Hong Da Rutun Marketing Co Ltd
⚠️ Moderate Risk
FEI: 3006348547 • Shenzhen City • CHINA
FEI Number
3006348547
Location
Shenzhen City
Country
CHINAAddress
Unit 10 Shen Nan Road Luo Hu Section, , Shenzhen City, , 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
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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 |
|---|---|---|---|
| 5/3/2013 | 79OMPNEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP | New Orleans District Office (NOL-DO) | |
| 5/3/2013 | 79OMPNEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Shenzhen Hong Da Rutun Marketing Co Ltd's FDA import refusal history?
Shenzhen Hong Da Rutun Marketing Co Ltd (FEI: 3006348547) has 2 FDA import refusal record(s) in our database, spanning from 5/3/2013 to 5/3/2013.
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. Shenzhen Hong Da Rutun Marketing Co Ltd's FEI number is 3006348547.
What types of violations has Shenzhen Hong Da Rutun Marketing Co Ltd received?
Shenzhen Hong Da Rutun Marketing Co 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 Shenzhen Hong Da Rutun Marketing Co Ltd come from?
All FDA import refusal data for Shenzhen Hong Da Rutun Marketing Co 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.