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High Momentum Sdn Bhd

⚠️ Moderate Risk

FEI: 3005907586 • Klang, Selangor • MALAYSIA

FEI

FEI Number

3005907586

📍

Location

Klang, Selangor

🇲🇾

Country

MALAYSIA
🏢

Address

No 12 Lorong Batu Nilam 6abandar, , Klang, Selangor, Malaysia

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
4/5/2010
Latest Refusal
1/20/2010
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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.

Refusal History

DateProductViolationsDivision
4/5/2010
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
New York District Office (NYK-DO)
1/20/2010
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is High Momentum Sdn Bhd's FDA import refusal history?

High Momentum Sdn Bhd (FEI: 3005907586) has 2 FDA import refusal record(s) in our database, spanning from 1/20/2010 to 4/5/2010.

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. High Momentum Sdn Bhd's FEI number is 3005907586.

What types of violations has High Momentum Sdn Bhd received?

High Momentum 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 High Momentum Sdn Bhd come from?

All FDA import refusal data for High Momentum 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.