Dexcowin Co. Ltd.
⚠️ Moderate Risk
FEI: 3007065358 • Geumcheon, Seoul • SOUTH KOREA
FEI Number
3007065358
Location
Geumcheon, Seoul
Country
SOUTH KOREAAddress
901~905 25 Gasan Digital 1-Ro, , Geumcheon, 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
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
NO TAG
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 to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
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 |
|---|---|---|---|
| 9/30/2018 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | Division of Southeast Imports (DSEI) | |
| 7/13/2018 | 90MUHSYSTEM, X-RAY, EXTRAORAL SOURCE, DIGITAL | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 10/25/2010 | 76EHDUNIT, X-RAY, EXTRAORAL WITH TIMER | 278NO TAG | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Dexcowin Co. Ltd.'s FDA import refusal history?
Dexcowin Co. Ltd. (FEI: 3007065358) has 3 FDA import refusal record(s) in our database, spanning from 10/25/2010 to 9/30/2018.
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. Dexcowin Co. Ltd.'s FEI number is 3007065358.
What types of violations has Dexcowin Co. Ltd. received?
Dexcowin 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 Dexcowin Co. Ltd. come from?
All FDA import refusal data for Dexcowin 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.