DE OTECH KOREA CO LTD
✅ Low Risk
FEI: 3012925821 • GYEONGGI-DO • SOUTH KOREA
FEI Number
3012925821
Location
GYEONGGI-DO
Country
SOUTH KOREAAddress
155 TONGILLO 642BEN-GIL, , GYEONGGI-DO, , 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 DE OTECH KOREA CO LTD's FDA import refusal history?
DE OTECH KOREA CO LTD (FEI: 3012925821) has 1 FDA import refusal record(s) in our database, spanning from 11/29/2016 to 11/29/2016.
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. DE OTECH KOREA CO LTD's FEI number is 3012925821.
What types of violations has DE OTECH KOREA CO LTD received?
DE OTECH KOREA CO LTD 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 DE OTECH KOREA CO LTD come from?
All FDA import refusal data for DE OTECH KOREA 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.