Shenzhen Shatoujiao 4th Village Yiqun Co Ltd
⚠️ Moderate Risk
FEI: 3007246665 • Shenzhen City • CHINA
FEI Number
3007246665
Location
Shenzhen City
Country
CHINAAddress
The 4th Village, Industrial Park,, , 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/7/2014 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | New Orleans District Office (NOL-DO) | |
| 10/7/2014 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | New Orleans District Office (NOL-DO) | |
| 10/7/2014 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Shenzhen Shatoujiao 4th Village Yiqun Co Ltd's FDA import refusal history?
Shenzhen Shatoujiao 4th Village Yiqun Co Ltd (FEI: 3007246665) has 3 FDA import refusal record(s) in our database, spanning from 10/7/2014 to 10/7/2014.
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 Shatoujiao 4th Village Yiqun Co Ltd's FEI number is 3007246665.
What types of violations has Shenzhen Shatoujiao 4th Village Yiqun Co Ltd received?
Shenzhen Shatoujiao 4th Village Yiqun Co 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 Shenzhen Shatoujiao 4th Village Yiqun Co Ltd come from?
All FDA import refusal data for Shenzhen Shatoujiao 4th Village Yiqun 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.