Kang-Ok Lee
✅ Low Risk
FEI: 3003986818 • Daejeon • SOUTH KOREA
FEI Number
3003986818
Location
Daejeon
Country
SOUTH KOREAAddress
101-305 Hanbap Garden Apt, , Daejeon, , 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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 Kang-Ok Lee's FDA import refusal history?
Kang-Ok Lee (FEI: 3003986818) has 1 FDA import refusal record(s) in our database, spanning from 5/6/2003 to 5/6/2003.
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. Kang-Ok Lee's FEI number is 3003986818.
What types of violations has Kang-Ok Lee received?
Kang-Ok Lee has been cited for 2 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 Kang-Ok Lee come from?
All FDA import refusal data for Kang-Ok Lee 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.