DK Innovision Co., Ltd
⚠️ Moderate Risk
FEI: 3010427966 • Cheonan, Chungcheongnam • SOUTH KOREA
FEI Number
3010427966
Location
Cheonan, Chungcheongnam
Country
SOUTH KOREAAddress
23 Busong1-Gil, Seobuk, Cheonan, Chungcheongnam, 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/30/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Seattle District Office (SEA-DO) | |
| 10/29/2013 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | Seattle District Office (SEA-DO) | |
| 10/29/2013 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | Seattle District Office (SEA-DO) | |
| 10/29/2013 | 86MVNLENS, CONTACT (DISPOSABLE) | Seattle District Office (SEA-DO) | |
| 10/29/2013 | 86MVNLENS, CONTACT (DISPOSABLE) | Seattle District Office (SEA-DO) | |
| 10/29/2013 | 86MVNLENS, CONTACT (DISPOSABLE) | Seattle District Office (SEA-DO) | |
| 10/29/2013 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | Seattle District Office (SEA-DO) | |
| 10/29/2013 | 86MVNLENS, CONTACT (DISPOSABLE) | Seattle District Office (SEA-DO) | |
| 10/29/2013 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | Seattle District Office (SEA-DO) | |
| 10/29/2013 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | Seattle District Office (SEA-DO) | |
| 10/29/2013 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | Seattle District Office (SEA-DO) | |
| 10/29/2013 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | Seattle District Office (SEA-DO) | |
| 10/29/2013 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | Seattle District Office (SEA-DO) | |
| 10/29/2013 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | Seattle District Office (SEA-DO) | |
| 10/29/2013 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | Seattle District Office (SEA-DO) | |
| 10/29/2013 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | Seattle District Office (SEA-DO) | |
| 10/9/2013 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | Seattle District Office (SEA-DO) | |
| 10/8/2013 | 86MVNLENS, CONTACT (DISPOSABLE) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is DK Innovision Co., Ltd's FDA import refusal history?
DK Innovision Co., Ltd (FEI: 3010427966) has 18 FDA import refusal record(s) in our database, spanning from 10/8/2013 to 10/30/2013.
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. DK Innovision Co., Ltd's FEI number is 3010427966.
What types of violations has DK Innovision Co., Ltd received?
DK Innovision Co., Ltd has been cited for 3 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 DK Innovision Co., Ltd come from?
All FDA import refusal data for DK Innovision 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.