Koon Seng Sdn Bhd
⚠️ Moderate Risk
FEI: 3595 • Pasir, Gudang • MALAYSIA
FEI Number
3595
Location
Pasir, Gudang
Country
MALAYSIAAddress
Plo 89, Jln Tembaga Dua, J H 4 1/2, , Pasir, Gudang, Malaysia
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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
Frequently Asked Questions
What is Koon Seng Sdn Bhd's FDA import refusal history?
Koon Seng Sdn Bhd (FEI: 3595) has 3 FDA import refusal record(s) in our database, spanning from 7/1/2009 to 7/1/2009.
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. Koon Seng Sdn Bhd's FEI number is 3595.
What types of violations has Koon Seng Sdn Bhd received?
Koon Seng 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 Koon Seng Sdn Bhd come from?
All FDA import refusal data for Koon Seng 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.