Shanghai Trend International Trade Co Ltd
⚠️ Moderate Risk
FEI: 3006295758 • Xinzhuang • CHINA
FEI Number
3006295758
Location
Xinzhuang
Country
CHINAAddress
Rm101 Bldg 65 Lane 400 Xinxi South Road, , Xinzhuang, , 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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
Frequently Asked Questions
What is Shanghai Trend International Trade Co Ltd's FDA import refusal history?
Shanghai Trend International Trade Co Ltd (FEI: 3006295758) has 2 FDA import refusal record(s) in our database, spanning from 10/2/2008 to 4/20/2009.
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. Shanghai Trend International Trade Co Ltd's FEI number is 3006295758.
What types of violations has Shanghai Trend International Trade Co Ltd received?
Shanghai Trend International Trade 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 Shanghai Trend International Trade Co Ltd come from?
All FDA import refusal data for Shanghai Trend International Trade 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.