Wanhang Intl Trade Co Ltd
⚠️ Moderate Risk
FEI: 3007649633 • Shanghai • CHINA
FEI Number
3007649633
Location
Shanghai
Country
CHINAAddress
No. 1399, Haining Rd, , Shanghai, , 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/24/2016 | 62H05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of West Coast Imports (DWCI) | |
| 2/24/2016 | 76EFWTOOTHBRUSH, MANUAL | Division of West Coast Imports (DWCI) | |
| 2/24/2016 | 80FQMBANDAGE, ELASTIC | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Wanhang Intl Trade Co Ltd's FDA import refusal history?
Wanhang Intl Trade Co Ltd (FEI: 3007649633) has 3 FDA import refusal record(s) in our database, spanning from 2/24/2016 to 2/24/2016.
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. Wanhang Intl Trade Co Ltd's FEI number is 3007649633.
What types of violations has Wanhang Intl Trade Co Ltd received?
Wanhang Intl Trade 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 Wanhang Intl Trade Co Ltd come from?
All FDA import refusal data for Wanhang Intl 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.