Top Union Interctronial Corp Ltd
⚠️ Moderate Risk
FEI: 3007073714 • Shenzhenshenzhen • CHINA
FEI Number
3007073714
Location
Shenzhenshenzhen
Country
CHINAAddress
1203-05 Cyber Times Tower A Tianan Cyber, , Shenzhenshenzhen, , 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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
Refusal History
Frequently Asked Questions
What is Top Union Interctronial Corp Ltd's FDA import refusal history?
Top Union Interctronial Corp Ltd (FEI: 3007073714) has 3 FDA import refusal record(s) in our database, spanning from 5/1/2009 to 12/11/2009.
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. Top Union Interctronial Corp Ltd's FEI number is 3007073714.
What types of violations has Top Union Interctronial Corp Ltd received?
Top Union Interctronial Corp 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 Top Union Interctronial Corp Ltd come from?
All FDA import refusal data for Top Union Interctronial Corp 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.