SHENZHEN HANGSEN STAR TECHNOLOGY CO., LTD
⚠️ Moderate Risk
FEI: 3012971571 • Shenzhen, Guangdong • CHINA
FEI Number
3012971571
Location
Shenzhen, Guangdong
Country
CHINAAddress
Hangsen Plaza, No. 3, Ganli Wu Rd., Buji, Long Gang District, , Shenzhen, Guangdong, 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
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
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 SHENZHEN HANGSEN STAR TECHNOLOGY CO., LTD's FDA import refusal history?
SHENZHEN HANGSEN STAR TECHNOLOGY CO., LTD (FEI: 3012971571) has 2 FDA import refusal record(s) in our database, spanning from 6/22/2020 to 10/19/2020.
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 HANGSEN STAR TECHNOLOGY CO., LTD's FEI number is 3012971571.
What types of violations has SHENZHEN HANGSEN STAR TECHNOLOGY CO., LTD received?
SHENZHEN HANGSEN STAR TECHNOLOGY 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 HANGSEN STAR TECHNOLOGY CO., LTD come from?
All FDA import refusal data for SHENZHEN HANGSEN STAR TECHNOLOGY 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.