ZHANGZHENG
⚠️ Moderate Risk
FEI: 3020786960 • Shenzhen, Guangdong • CHINA
FEI Number
3020786960
Location
Shenzhen, Guangdong
Country
CHINAAddress
Heng Li Zhen Tianraobu, , 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
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 ZHANGZHENG's FDA import refusal history?
ZHANGZHENG (FEI: 3020786960) has 3 FDA import refusal record(s) in our database, spanning from 9/7/2023 to 9/7/2023.
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. ZHANGZHENG's FEI number is 3020786960.
What types of violations has ZHANGZHENG received?
ZHANGZHENG has been cited for 1 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 ZHANGZHENG come from?
All FDA import refusal data for ZHANGZHENG 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.