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Terang Nusa Sdn Bhd

⚠️ Moderate Risk

FEI: 3367 • Batu Caves, Selangor • MALAYSIA

FEI

FEI Number

3367

📍

Location

Batu Caves, Selangor

🇲🇾

Country

MALAYSIA
🏢

Address

Baru Industrial Estate, 17503 Jalan Empat, Batu Caves, Selangor, Malaysia

Moderate Risk

FDA Import Risk Assessment

50.0
LowModerateHighCritical

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

Statistics

11
Total Refusals
1
Unique Violations
1/31/2002
Latest Refusal
12/17/2001
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
40.0×30%
Recency
0.0×20%
Frequency
100.0×10%
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

47711×

HOLES

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

Refusal History

DateProductViolationsDivision
1/31/2002
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Los Angeles District Office (LOS-DO)
1/31/2002
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Los Angeles District Office (LOS-DO)
1/31/2002
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Los Angeles District Office (LOS-DO)
1/31/2002
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Los Angeles District Office (LOS-DO)
1/31/2002
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Los Angeles District Office (LOS-DO)
1/31/2002
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Los Angeles District Office (LOS-DO)
1/31/2002
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Los Angeles District Office (LOS-DO)
1/31/2002
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Los Angeles District Office (LOS-DO)
1/31/2002
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Los Angeles District Office (LOS-DO)
1/31/2002
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Los Angeles District Office (LOS-DO)
12/17/2001
80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY
477HOLES
Chicago District Office (CHI-DO)

Frequently Asked Questions

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

Terang Nusa Sdn Bhd (FEI: 3367) has 11 FDA import refusal record(s) in our database, spanning from 12/17/2001 to 1/31/2002.

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 3367.

What types of violations has Terang Nusa Sdn Bhd received?

Terang Nusa 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 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.