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N. S. Uni-Gloves Sdn. Bhd.

⚠️ Moderate Risk

FEI: 3430 • Seremban, Negeri Sembilan • MALAYSIA

FEI

FEI Number

3430

📍

Location

Seremban, Negeri Sembilan

🇲🇾

Country

MALAYSIA
🏢

Address

Lot 3, Jalan Senawang, Seremban, Negeri Sembilan, Malaysia

Moderate Risk

FDA Import Risk Assessment

39.3
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
7/22/2011
Latest Refusal
9/9/2009
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
26.8×10%
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

4775×

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
7/22/2011
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
New York District Office (NYK-DO)
7/22/2011
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
New York District Office (NYK-DO)
7/22/2011
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
New York District Office (NYK-DO)
7/22/2011
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
New York District Office (NYK-DO)
9/9/2009
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is N. S. Uni-Gloves Sdn. Bhd.'s FDA import refusal history?

N. S. Uni-Gloves Sdn. Bhd. (FEI: 3430) has 5 FDA import refusal record(s) in our database, spanning from 9/9/2009 to 7/22/2011.

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. N. S. Uni-Gloves Sdn. Bhd.'s FEI number is 3430.

What types of violations has N. S. Uni-Gloves Sdn. Bhd. received?

N. S. Uni-Gloves 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 N. S. Uni-Gloves Sdn. Bhd. come from?

All FDA import refusal data for N. S. Uni-Gloves 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.