MAXVUE VISION SDN BHD

⚠️ High Risk

FEI: 3012760082 • Seremban, Negeri Sembilan • MALAYSIA

FEI

FEI Number

3012760082

📍

Location

Seremban, Negeri Sembilan

🇲🇾

Country

MALAYSIA

🏢

Address

NO 280 Jalan Haruan 1, , Seremban, Negeri Sembilan, Malaysia

High Risk

FDA Import Risk Assessment

63.9

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

11/17/2025

Latest Refusal

10/25/2016

Earliest Refusal

Score Breakdown

Violation Severity

56.4×40%

Refusal Volume

58.9×30%

Recency

97.0×20%

Frequency

41.9×10%

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

Violation Summary

11836×

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).

328034×

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.

50834×

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.

24805×

RXPERSONAL

The article appears to be a device which requires a prescription from your doctor.

3414×

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).

161×

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.

841×

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
11/17/2025	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
12/4/2023	86LPLLENSES, SOFT CONTACT, DAILY WEAR	508NO 510(K)	Division of Southeast Imports (DSEI)
12/1/2021	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
1/27/2020	86LPMLENSES, SOFT CONTACT, EXTENDED WEAR	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
6/24/2019	86MVNLENS, CONTACT (DISPOSABLE)	341REGISTERED	Division of Southeast Imports (DSEI)
6/7/2019	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
12/10/2016	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/22/2016	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New York District Office (NYK-DO)
11/22/2016	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New York District Office (NYK-DO)
11/18/2016	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/18/2016	86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/18/2016	86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/18/2016	86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/18/2016	86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/18/2016	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/18/2016	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/18/2016	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/18/2016	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/18/2016	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/18/2016	86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/18/2016	86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/18/2016	86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/18/2016	86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/18/2016	86LPMLENSES, SOFT CONTACT, EXTENDED WEAR	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/18/2016	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/18/2016	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/18/2016	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/18/2016	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
11/17/2016	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED	New Orleans District Office (NOL-DO)
11/15/2016	86NICLENS, CONTACT, FOR READING DISCOMFORT	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	New York District Office (NYK-DO)
11/15/2016	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	New York District Office (NYK-DO)
11/15/2016	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	New York District Office (NYK-DO)
11/9/2016	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/8/2016	86LPMLENSES, SOFT CONTACT, EXTENDED WEAR	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New York District Office (NYK-DO)
11/2/2016	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/2/2016	86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
10/26/2016	86LPMLENSES, SOFT CONTACT, EXTENDED WEAR	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	New York District Office (NYK-DO)
10/25/2016	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K) 84RX DEVICE	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is MAXVUE VISION SDN BHD's FDA import refusal history?

MAXVUE VISION SDN BHD (FEI: 3012760082) has 38 FDA import refusal record(s) in our database, spanning from 10/25/2016 to 11/17/2025.

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 3012760082.

What types of violations has MAXVUE VISION SDN BHD received?

MAXVUE VISION SDN BHD has been cited for 7 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.