Vassen Co. Ltd.
⚠️ High Risk
FEI: 3008034930 • Pyongtaek City, Gyeonggi-di • SOUTH KOREA
FEI Number
3008034930
Location
Pyongtaek City, Gyeonggi-di
Country
SOUTH KOREAAddress
260-1 Habuk-Ri Jinwee-Myun, , Pyongtaek City, Gyeonggi-di, South Korea
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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.
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(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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.
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 PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/24/2025 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/29/2022 | 86MVNLENS, CONTACT (DISPOSABLE) | Division of Southeast Imports (DSEI) | |
| 9/12/2022 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 8/11/2022 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 6/30/2017 | 86MVNLENS, CONTACT (DISPOSABLE) | Division of Southeast Imports (DSEI) | |
| 5/23/2017 | 86MSISOLUTION, CLEANING/LUBRICATING, ARTICIFIAL EYE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/23/2017 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/24/2017 | 86LYLACCESSORIES TO CONTACT LENS SOLUTION | Detroit District Office (DET-DO) | |
| 1/24/2017 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Detroit District Office (DET-DO) | |
| 1/13/2017 | 86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS | Division of Southeast Imports (DSEI) | |
| 1/13/2017 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 1/11/2017 | 86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS | Division of Southeast Imports (DSEI) | |
| 1/11/2017 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 1/6/2017 | 86LYLACCESSORIES TO CONTACT LENS SOLUTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/6/2017 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 1/4/2017 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 12/23/2016 | 86LYLACCESSORIES TO CONTACT LENS SOLUTION | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/23/2016 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/21/2016 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 12/21/2016 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 12/21/2016 | 86LYLACCESSORIES TO CONTACT LENS SOLUTION | New Orleans District Office (NOL-DO) | |
| 12/17/2016 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | 223FALSE | New Orleans District Office (NOL-DO) |
| 12/17/2016 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | 223FALSE | New Orleans District Office (NOL-DO) |
| 11/30/2016 | 86LYLACCESSORIES TO CONTACT LENS SOLUTION | Division of Southeast Imports (DSEI) | |
| 11/30/2016 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 11/18/2016 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 11/18/2016 | 86LYLACCESSORIES TO CONTACT LENS SOLUTION | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 11/18/2016 | 86MSISOLUTION, CLEANING/LUBRICATING, ARTICIFIAL EYE | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 11/18/2016 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 11/17/2016 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 84RX DEVICE | New Orleans District Office (NOL-DO) |
| 10/24/2016 | 86MSISOLUTION, CLEANING/LUBRICATING, ARTICIFIAL EYE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/12/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Seattle District Office (SEA-DO) | |
| 5/8/2015 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | New Orleans District Office (NOL-DO) | |
| 5/8/2015 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | New Orleans District Office (NOL-DO) | |
| 10/3/2014 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | Seattle District Office (SEA-DO) |
| 8/13/2014 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Seattle District Office (SEA-DO) | |
| 1/3/2014 | 86MVNLENS, CONTACT (DISPOSABLE) | New Orleans District Office (NOL-DO) | |
| 6/6/2013 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 11/28/2012 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | Seattle District Office (SEA-DO) | |
| 3/20/2012 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | Seattle District Office (SEA-DO) | |
| 3/5/2012 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | New Orleans District Office (NOL-DO) | |
| 1/7/2012 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/30/2011 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | San Francisco District Office (SAN-DO) | |
| 3/16/2011 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Vassen Co. Ltd.'s FDA import refusal history?
Vassen Co. Ltd. (FEI: 3008034930) has 44 FDA import refusal record(s) in our database, spanning from 3/16/2011 to 1/24/2025.
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. Vassen Co. Ltd.'s FEI number is 3008034930.
What types of violations has Vassen Co. Ltd. received?
Vassen Co. Ltd. has been cited for 10 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 Vassen Co. Ltd. come from?
All FDA import refusal data for Vassen 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.