WELL LEAD MEDICAL INSTRUMENTS CO.,LTD
⚠️ Moderate Risk
FEI: 3015106513 • Guangzhou, Guangdong • CHINA
FEI Number
3015106513
Location
Guangzhou, Guangdong
Country
CHINAAddress
A4-18 Jinhu Industrialestate, Hualong Gongye Road; Hualongzhen Fanyu, Guangzhou, 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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
3904
3905
Refusal History
Frequently Asked Questions
What is WELL LEAD MEDICAL INSTRUMENTS CO.,LTD's FDA import refusal history?
WELL LEAD MEDICAL INSTRUMENTS CO.,LTD (FEI: 3015106513) has 1 FDA import refusal record(s) in our database, spanning from 12/23/2025 to 12/23/2025.
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. WELL LEAD MEDICAL INSTRUMENTS CO.,LTD's FEI number is 3015106513.
What types of violations has WELL LEAD MEDICAL INSTRUMENTS CO.,LTD received?
WELL LEAD MEDICAL INSTRUMENTS CO.,LTD has been cited for 3 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 WELL LEAD MEDICAL INSTRUMENTS CO.,LTD come from?
All FDA import refusal data for WELL LEAD MEDICAL INSTRUMENTS 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.