WELL LEAD MEDICAL CO. LTD
⚠️ Moderate Risk
FEI: 3010400865 • Guangzhou, Guangdong • CHINA
FEI Number
3010400865
Location
Guangzhou, Guangdong
Country
CHINAAddress
NO. 47 Guomao Avenue South , Panyu, , 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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/29/2018 | 73BTRTUBE, TRACHEAL (W/WO CONNECTOR) | 479DV QUALITY | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is WELL LEAD MEDICAL CO. LTD's FDA import refusal history?
WELL LEAD MEDICAL CO. LTD (FEI: 3010400865) has 1 FDA import refusal record(s) in our database, spanning from 3/29/2018 to 3/29/2018.
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 CO. LTD's FEI number is 3010400865.
What types of violations has WELL LEAD MEDICAL CO. LTD received?
WELL LEAD MEDICAL 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 WELL LEAD MEDICAL CO. LTD come from?
All FDA import refusal data for WELL LEAD MEDICAL 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.