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Quality Latex Corp. Sdn Bhd

⚠️ Moderate Risk

FEI: 3860 • Ipoh, Perak • MALAYSIA

FEI

FEI Number

3860

📍

Location

Ipoh, Perak

🇲🇾

Country

MALAYSIA
🏢

Address

18 Jalan Kilang 2, , Ipoh, Perak, Malaysia

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/14/2007
Latest Refusal
8/14/2007
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

4771×

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
8/14/2007
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
New York District Office (NYK-DO)

Frequently Asked Questions

What is Quality Latex Corp. Sdn Bhd's FDA import refusal history?

Quality Latex Corp. Sdn Bhd (FEI: 3860) has 1 FDA import refusal record(s) in our database, spanning from 8/14/2007 to 8/14/2007.

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. Quality Latex Corp. Sdn Bhd's FEI number is 3860.

What types of violations has Quality Latex Corp. Sdn Bhd received?

Quality Latex Corp. 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 Quality Latex Corp. Sdn Bhd come from?

All FDA import refusal data for Quality Latex Corp. 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.