Tianjin Wanhua Teconology Development Co., Ltd
⚠️ Moderate Risk
FEI: 3011052530 • Tianjin-hexi • CHINA
FEI Number
3011052530
Location
Tianjin-hexi
Country
CHINAAddress
Yinjing 8-2-1303, East Five Street, , Tianjin-hexi, , 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
Frequently Asked Questions
What is Tianjin Wanhua Teconology Development Co., Ltd's FDA import refusal history?
Tianjin Wanhua Teconology Development Co., Ltd (FEI: 3011052530) has 1 FDA import refusal record(s) in our database, spanning from 12/19/2014 to 12/19/2014.
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. Tianjin Wanhua Teconology Development Co., Ltd's FEI number is 3011052530.
What types of violations has Tianjin Wanhua Teconology Development Co., Ltd received?
Tianjin Wanhua Teconology Development 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 Tianjin Wanhua Teconology Development Co., Ltd come from?
All FDA import refusal data for Tianjin Wanhua Teconology Development 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.