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Seltom Pacific Sdn. Bhd.

⚠️ Moderate Risk

FEI: 3003804898 • Beranang, Selangor • MALAYSIA

FEI

FEI Number

3003804898

📍

Location

Beranang, Selangor

🇲🇾

Country

MALAYSIA
🏢

Address

Lot Pt, 153 Kawasan Perusahaan, Jalan Besar Beranang, Beranang, Selangor, Malaysia

Moderate Risk

FDA Import Risk Assessment

37.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
2/14/2005
Latest Refusal
9/29/2004
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

4773×

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
2/14/2005
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Southwest Import District Office (SWI-DO)
10/7/2004
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
New York District Office (NYK-DO)
9/29/2004
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Seltom Pacific Sdn. Bhd.'s FDA import refusal history?

Seltom Pacific Sdn. Bhd. (FEI: 3003804898) has 3 FDA import refusal record(s) in our database, spanning from 9/29/2004 to 2/14/2005.

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. Seltom Pacific Sdn. Bhd.'s FEI number is 3003804898.

What types of violations has Seltom Pacific Sdn. Bhd. received?

Seltom Pacific 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 Seltom Pacific Sdn. Bhd. come from?

All FDA import refusal data for Seltom Pacific 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.