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ALCON LABORATORIES (M) SDN BHD

⚠️ Moderate Risk

FEI: 3014436872 • Petaling Jaya, Selangor • MALAYSIA

FEI

FEI Number

3014436872

📍

Location

Petaling Jaya, Selangor

🇲🇾

Country

MALAYSIA
🏢

Address

Level 22, Tower B, Plaza 33, No. 1 Jalan Kemajuan, Petaling Jaya, Selangor, Malaysia

Moderate Risk

FDA Import Risk Assessment

25.2
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
12/9/2021
Latest Refusal
12/9/2021
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
4.2×20%
Frequency
10.0×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

1181×

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).

Refusal History

DateProductViolationsDivision
12/9/2021
86LPMLENSES, SOFT CONTACT, EXTENDED WEAR
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ALCON LABORATORIES (M) SDN BHD's FDA import refusal history?

ALCON LABORATORIES (M) SDN BHD (FEI: 3014436872) has 1 FDA import refusal record(s) in our database, spanning from 12/9/2021 to 12/9/2021.

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. ALCON LABORATORIES (M) SDN BHD's FEI number is 3014436872.

What types of violations has ALCON LABORATORIES (M) SDN BHD received?

ALCON LABORATORIES (M) SDN BHD has been cited for 1 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 ALCON LABORATORIES (M) SDN BHD come from?

All FDA import refusal data for ALCON LABORATORIES (M) 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.