Lien Nha Co Ltd
✅ Low Risk
FEI: 3005476434 • Ho Chi Minhho Chi Minh • VIETNAM
FEI Number
3005476434
Location
Ho Chi Minhho Chi Minh
Country
VIETNAMAddress
175 Su Van Hanh Stdist 10, , Ho Chi Minhho Chi Minh, , Vietnam
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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 Lien Nha Co Ltd's FDA import refusal history?
Lien Nha Co Ltd (FEI: 3005476434) has 2 FDA import refusal record(s) in our database, spanning from 1/17/2006 to 1/17/2006.
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. Lien Nha Co Ltd's FEI number is 3005476434.
What types of violations has Lien Nha Co Ltd received?
Lien Nha 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 Lien Nha Co Ltd come from?
All FDA import refusal data for Lien Nha 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.