Do Wool Co Ltd
✅ Low Risk
FEI: 3011340509 • Seoul • SOUTH KOREA
FEI Number
3011340509
Location
Seoul
Country
SOUTH KOREAAddress
481-3 Guro-Dong Gurogu, , Seoul, , 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
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).
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/21/2016 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 10/13/2016 | 63RAY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of Northeast Imports (DNEI) | |
| 3/18/2015 | 76EFWTOOTHBRUSH, MANUAL | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Do Wool Co Ltd's FDA import refusal history?
Do Wool Co Ltd (FEI: 3011340509) has 3 FDA import refusal record(s) in our database, spanning from 3/18/2015 to 10/21/2016.
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. Do Wool Co Ltd's FEI number is 3011340509.
What types of violations has Do Wool Co Ltd received?
Do Wool 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 Do Wool Co Ltd come from?
All FDA import refusal data for Do Wool 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.