YOUNGJIN KOSTEN CO LTD
⚠️ Moderate Risk
FEI: 3030269295 • Seoul • SOUTH KOREA
FEI Number
3030269295
Location
Seoul
Country
SOUTH KOREAAddress
40 Gukhoe-Daero 7gil Gangseo-Gu, , Seoul, , South Korea
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/31/2024 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is YOUNGJIN KOSTEN CO LTD's FDA import refusal history?
YOUNGJIN KOSTEN CO LTD (FEI: 3030269295) has 1 FDA import refusal record(s) in our database, spanning from 1/31/2024 to 1/31/2024.
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. YOUNGJIN KOSTEN CO LTD's FEI number is 3030269295.
What types of violations has YOUNGJIN KOSTEN CO LTD received?
YOUNGJIN KOSTEN 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 YOUNGJIN KOSTEN CO LTD come from?
All FDA import refusal data for YOUNGJIN KOSTEN 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.