BEIJING HOTGEN BIOTECH CO LTD
⚠️ High Risk
FEI: 3032869372 • Beijing, Beijing • CHINA
FEI Number
3032869372
Location
Beijing, Beijing
Country
CHINAAddress
Bldg 9th, 9 Tianan Street, Beijing, Beijing, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
Frequently Asked Questions
What is BEIJING HOTGEN BIOTECH CO LTD's FDA import refusal history?
BEIJING HOTGEN BIOTECH CO LTD (FEI: 3032869372) has 2 FDA import refusal record(s) in our database, spanning from 5/28/2025 to 7/15/2025.
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. BEIJING HOTGEN BIOTECH CO LTD's FEI number is 3032869372.
What types of violations has BEIJING HOTGEN BIOTECH CO LTD received?
BEIJING HOTGEN BIOTECH CO LTD 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 BEIJING HOTGEN BIOTECH CO LTD come from?
All FDA import refusal data for BEIJING HOTGEN BIOTECH 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.