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TERANG NUSA (MALAYSIA) SDN. BHD.

⚠️ Moderate Risk

FEI: 3012304897 • Kota Bharu, Kelantan • MALAYSIA

FEI

FEI Number

3012304897

📍

Location

Kota Bharu, Kelantan

🇲🇾

Country

MALAYSIA
🏢

Address

2 Jalan 8, Pengkalan Chepa Industrial Zone 2, , Kota Bharu, Kelantan, Malaysia

Moderate Risk

FDA Import Risk Assessment

36.4
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
9/3/2020
Latest Refusal
8/10/2020
Earliest Refusal

Score Breakdown

Violation Severity
66.7×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

4772×

HOLES

The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.

2231×

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.

Refusal History

DateProductViolationsDivision
9/3/2020
80FMCGLOVE, PATIENT EXAMINATION
223FALSE
Division of Southeast Imports (DSEI)
8/10/2020
80LZAGLOVE, PATIENT EXAMINATION, POLY
477HOLES
Division of West Coast Imports (DWCI)
8/10/2020
80LZAGLOVE, PATIENT EXAMINATION, POLY
477HOLES
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is TERANG NUSA (MALAYSIA) SDN. BHD.'s FDA import refusal history?

TERANG NUSA (MALAYSIA) SDN. BHD. (FEI: 3012304897) has 3 FDA import refusal record(s) in our database, spanning from 8/10/2020 to 9/3/2020.

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. TERANG NUSA (MALAYSIA) SDN. BHD.'s FEI number is 3012304897.

What types of violations has TERANG NUSA (MALAYSIA) SDN. BHD. received?

TERANG NUSA (MALAYSIA) 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 TERANG NUSA (MALAYSIA) SDN. BHD. come from?

All FDA import refusal data for TERANG NUSA (MALAYSIA) 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.