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HARTALEGA NGC SDN BHD

⚠️ Moderate Risk

FEI: 3011200663 • Sepang, Selangor • MALAYSIA

FEI

FEI Number

3011200663

📍

Location

Sepang, Selangor

🇲🇾

Country

MALAYSIA
🏢

Address

No.1 Persiaran Tanjung Kawasan, Perindustrian Tanjung, Sepang, Selangor, Malaysia

Moderate Risk

FDA Import Risk Assessment

38.2
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
7/3/2025
Latest Refusal
7/3/2025
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
89.3×20%
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

39051×

3905

5081×

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.

Refusal History

DateProductViolationsDivision
7/3/2025
80LYYGLOVE, PATIENT EXAMINATION, LATEX
39053905
508NO 510(K)
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is HARTALEGA NGC SDN BHD's FDA import refusal history?

HARTALEGA NGC SDN BHD (FEI: 3011200663) has 1 FDA import refusal record(s) in our database, spanning from 7/3/2025 to 7/3/2025.

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. HARTALEGA NGC SDN BHD's FEI number is 3011200663.

What types of violations has HARTALEGA NGC SDN BHD received?

HARTALEGA NGC SDN BHD has been cited for 2 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 HARTALEGA NGC SDN BHD come from?

All FDA import refusal data for HARTALEGA NGC 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.