Terang Nusa Sdn. Bhd.

⚠️ Moderate Risk

FEI: 3002700151 • Kota Bharu, Kelantan • MALAYSIA

FEI

FEI Number

3002700151

📍

Location

Kota Bharu, Kelantan

🇲🇾

Country

MALAYSIA

🏢

Address

No. 1 Jalan 8 Pengkalan Chepa 2, , Kota Bharu, Kelantan, Malaysia

Moderate Risk

FDA Import Risk Assessment

39.4

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

12/14/2020

Latest Refusal

9/11/2006

Earliest Refusal

Score Breakdown

Violation Severity

66.7×40%

Refusal Volume

40.0×30%

Recency

0.0×20%

Frequency

7.7×10%

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

4779×

HOLES

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

1182×

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).

27801×

DEVICEGMPS

The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.

Refusal History

Date	Product	Violations	Division
12/14/2020	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	2780DEVICEGMPS 477HOLES	Division of Southeast Imports (DSEI)
12/2/2011	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Philadelphia District Office (PHI-DO)
12/2/2011	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Philadelphia District Office (PHI-DO)
12/2/2011	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Philadelphia District Office (PHI-DO)
12/2/2011	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Philadelphia District Office (PHI-DO)
11/4/2011	80LYYGLOVE, PATIENT EXAMINATION, LATEX	477HOLES	Philadelphia District Office (PHI-DO)
11/4/2011	80LYYGLOVE, PATIENT EXAMINATION, LATEX	477HOLES	Philadelphia District Office (PHI-DO)
6/8/2009	79KGOSURGEON'S GLOVES	477HOLES	New Orleans District Office (NOL-DO)
7/20/2007	79KGOSURGEON'S GLOVES	477HOLES	Florida District Office (FLA-DO)
9/11/2006	79KGOSURGEON'S GLOVES	118NOT LISTED	New York District Office (NYK-DO)
9/11/2006	79KGOSURGEON'S GLOVES	118NOT LISTED	New York District Office (NYK-DO)

Frequently Asked Questions

What is Terang Nusa Sdn. Bhd.'s FDA import refusal history?

Terang Nusa Sdn. Bhd. (FEI: 3002700151) has 11 FDA import refusal record(s) in our database, spanning from 9/11/2006 to 12/14/2020.

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 Sdn. Bhd.'s FEI number is 3002700151.

What types of violations has Terang Nusa Sdn. Bhd. received?

Terang Nusa Sdn. Bhd. has been cited for 3 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 Sdn. Bhd. come from?

All FDA import refusal data for Terang Nusa 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.