Neo Vision Co., Ltd.
⚠️ Moderate Risk
FEI: 3005747991 • Icheon, Gyeonggi • SOUTH KOREA
FEI Number
3005747991
Location
Icheon, Gyeonggi
Country
SOUTH KOREAAddress
93 Jeungsin-Ro, , Icheon, Gyeonggi, 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).
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).
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.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/18/2013 | 86MVNLENS, CONTACT (DISPOSABLE) | Cincinnati District Office (CIN-DO) | |
| 1/7/2012 | 86HPXLENS, CONTACT (POLYMETHYLMETHACRYLATE) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 86NCZLENS, CONTACT, FOR COLOR VISION DEFICIENCY | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/8/2011 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/16/2011 | 86MVNLENS, CONTACT (DISPOSABLE) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Neo Vision Co., Ltd.'s FDA import refusal history?
Neo Vision Co., Ltd. (FEI: 3005747991) has 5 FDA import refusal record(s) in our database, spanning from 3/16/2011 to 1/18/2013.
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. Neo Vision Co., Ltd.'s FEI number is 3005747991.
What types of violations has Neo Vision Co., Ltd. received?
Neo Vision 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 Neo Vision Co., Ltd. come from?
All FDA import refusal data for Neo Vision 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.