Visco Co. Ltd
✅ Low Risk
FEI: 3005841814 • Seoul • SOUTH KOREA
FEI Number
3005841814
Location
Seoul
Country
SOUTH KOREAAddress
511-2 Chung Kye Dong, , Seoul, , South Korea
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 Visco Co. Ltd's FDA import refusal history?
Visco Co. Ltd (FEI: 3005841814) has 2 FDA import refusal record(s) in our database, spanning from 10/16/2006 to 10/16/2006.
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. Visco Co. Ltd's FEI number is 3005841814.
What types of violations has Visco Co. Ltd received?
Visco 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 Visco Co. Ltd come from?
All FDA import refusal data for Visco 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.