WON TECH Co Ltd
⚠️ Moderate Risk
FEI: 3006985208 • Yuseong • SOUTH KOREA
FEI Number
3006985208
Location
Yuseong
Country
SOUTH KOREAAddress
64 Techno 8-Ro, Daejeon, Yuseong, , 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
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).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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 |
|---|---|---|---|
| 1/18/2018 | 79MVFSYSTEM, LASER, PHOTODYNAMIC THERAPY | Division of Southeast Imports (DSEI) | |
| 4/14/2011 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Cincinnati District Office (CIN-DO) | |
| 2/3/2011 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Chicago District Office (CHI-DO) | |
| 1/27/2011 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Chicago District Office (CHI-DO) | |
| 7/13/2007 | 79NAGLIGHT, SPECTRUM, BROAD | Minneapolis District Office (MIN-DO) | |
| 7/13/2007 | 79NAGLIGHT, SPECTRUM, BROAD | Minneapolis District Office (MIN-DO) |
Frequently Asked Questions
What is WON TECH Co Ltd's FDA import refusal history?
WON TECH Co Ltd (FEI: 3006985208) has 6 FDA import refusal record(s) in our database, spanning from 7/13/2007 to 1/18/2018.
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. WON TECH Co Ltd's FEI number is 3006985208.
What types of violations has WON TECH Co Ltd received?
WON TECH Co Ltd has been cited for 4 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 WON TECH Co Ltd come from?
All FDA import refusal data for WON TECH 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.