Maxvue Vision Sdn Bhd
⚠️ High Risk
FEI: 3008070629 • Negeri Sembilan • MALAYSIA
FEI Number
3008070629
Location
Negeri Sembilan
Country
MALAYSIAAddress
614 1 Jalan Haruan 4 8, , Negeri Sembilan, , Malaysia
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.
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).
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.
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).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
LENS CERT
The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/8/2025 | 86MVNLENS, CONTACT (DISPOSABLE) | Division of Southeast Imports (DSEI) | |
| 4/6/2022 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/8/2020 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/8/2020 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/8/2020 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/28/2020 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 8/6/2020 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/3/2020 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/3/2020 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/4/2019 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/8/2017 | 86HPXLENS, CONTACT (POLYMETHYLMETHACRYLATE) | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/18/2017 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 6/23/2017 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 12/23/2016 | 86MVNLENS, CONTACT (DISPOSABLE) | New Orleans District Office (NOL-DO) | |
| 3/17/2016 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | 508NO 510(K) | Seattle District Office (SEA-DO) |
| 3/17/2016 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | 508NO 510(K) | Seattle District Office (SEA-DO) |
| 1/27/2016 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Seattle District Office (SEA-DO) | |
| 1/22/2016 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 12/1/2015 | 86MVNLENS, CONTACT (DISPOSABLE) | Division of Southeast Imports (DSEI) | |
| 11/23/2015 | 86MZDSYSTEM, IN-OFFICE TINTING, CONTACT LENSES | Division of Southeast Imports (DSEI) | |
| 11/20/2015 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | Division of Southeast Imports (DSEI) | |
| 11/19/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 11/19/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 11/19/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 11/18/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 11/17/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 11/17/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 11/17/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 11/9/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 10/27/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 9/23/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 4/3/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 11/3/2014 | 86MVNLENS, CONTACT (DISPOSABLE) | Cincinnati District Office (CIN-DO) | |
| 1/14/2014 | 86HPXLENS, CONTACT (POLYMETHYLMETHACRYLATE) | New York District Office (NYK-DO) | |
| 1/10/2014 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 12/9/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 12/9/2013 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | New Orleans District Office (NOL-DO) | |
| 11/20/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New York District Office (NYK-DO) | |
| 10/22/2013 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | Detroit District Office (DET-DO) |
| 10/22/2013 | 65RDK12POTASSIC SALINE (INJECTION) (REPLENISHER) | 118NOT LISTED | Detroit District Office (DET-DO) |
| 1/23/2013 | 86LRXCASE, CONTACT LENS | New Orleans District Office (NOL-DO) | |
| 1/23/2013 | 86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS | New Orleans District Office (NOL-DO) | |
| 1/23/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 4/30/2012 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 12/6/2011 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 12/2/2011 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | 237NO PMA | New Orleans District Office (NOL-DO) |
| 12/2/2011 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 6/23/2011 | 86MVNLENS, CONTACT (DISPOSABLE) | Cincinnati District Office (CIN-DO) | |
| 6/23/2011 | 86MVNLENS, CONTACT (DISPOSABLE) | Cincinnati District Office (CIN-DO) | |
| 9/21/2010 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | 118NOT LISTED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Maxvue Vision Sdn Bhd's FDA import refusal history?
Maxvue Vision Sdn Bhd (FEI: 3008070629) has 50 FDA import refusal record(s) in our database, spanning from 9/21/2010 to 1/8/2025.
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. Maxvue Vision Sdn Bhd's FEI number is 3008070629.
What types of violations has Maxvue Vision Sdn Bhd received?
Maxvue Vision Sdn Bhd has been cited for 11 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 Maxvue Vision Sdn Bhd come from?
All FDA import refusal data for Maxvue Vision Sdn Bhd 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.