GUANDONG BIOMEDITECH CO LTD
⚠️ Moderate Risk
FEI: 3016644702 • Zhuhai • 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 GUANDONG BIOMEDITECH CO LTD's FDA import refusal history?
GUANDONG BIOMEDITECH CO LTD (FEI: 3016644702) has 2 FDA import refusal record(s) in our database, spanning from 6/17/2022 to 7/26/2023.
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. GUANDONG BIOMEDITECH CO LTD's FEI number is 3016644702.
What types of violations has GUANDONG BIOMEDITECH CO LTD received?
GUANDONG BIOMEDITECH 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 GUANDONG BIOMEDITECH CO LTD come from?
All FDA import refusal data for GUANDONG BIOMEDITECH 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.