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Sony Emcs (Malaysia) Sdn Bhd(Company No. 183842-X)

⚠️ Moderate Risk

FEI: 3005623510 • Pengan • MALAYSIA

FEI

FEI Number

3005623510

📍

Location

Pengan

🇲🇾

Country

MALAYSIA
🏢

Address

Free Trade Zone, Parai Industrial Estate, , Prai, Pengan, , 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
11/3/2006
Latest Refusal
8/24/2006
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

473×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
11/3/2006
95L32CD PLAYER COMBINATION SYSTEMS
47NON STD
Florida District Office (FLA-DO)
9/18/2006
95L32CD PLAYER COMBINATION SYSTEMS
47NON STD
Florida District Office (FLA-DO)
8/24/2006
95L32CD PLAYER COMBINATION SYSTEMS
47NON STD
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Sony Emcs (Malaysia) Sdn Bhd(Company No. 183842-X)'s FDA import refusal history?

Sony Emcs (Malaysia) Sdn Bhd(Company No. 183842-X) (FEI: 3005623510) has 3 FDA import refusal record(s) in our database, spanning from 8/24/2006 to 11/3/2006.

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. Sony Emcs (Malaysia) Sdn Bhd(Company No. 183842-X)'s FEI number is 3005623510.

What types of violations has Sony Emcs (Malaysia) Sdn Bhd(Company No. 183842-X) received?

Sony Emcs (Malaysia) Sdn Bhd(Company No. 183842-X) 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 Sony Emcs (Malaysia) Sdn Bhd(Company No. 183842-X) come from?

All FDA import refusal data for Sony Emcs (Malaysia) Sdn Bhd(Company No. 183842-X) 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.