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Supercomal Medical Products Sdn Bhd

⚠️ Moderate Risk

FEI: 3005115704 • Kedah • MALAYSIA

FEI

FEI Number

3005115704

📍

Location

Kedah

🇲🇾

Country

MALAYSIA
🏢

Address

Lot 171 Jalan Pknk 3/8 Kawasan Per, , Kedah, , Malaysia

Moderate Risk

FDA Import Risk Assessment

27.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/5/2022
Latest Refusal
8/5/2022
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
17.3×20%
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

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
8/5/2022
74DXGCOMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
3280FRNMFGREG
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is Supercomal Medical Products Sdn Bhd's FDA import refusal history?

Supercomal Medical Products Sdn Bhd (FEI: 3005115704) has 1 FDA import refusal record(s) in our database, spanning from 8/5/2022 to 8/5/2022.

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. Supercomal Medical Products Sdn Bhd's FEI number is 3005115704.

What types of violations has Supercomal Medical Products Sdn Bhd received?

Supercomal Medical Products 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 Supercomal Medical Products Sdn Bhd come from?

All FDA import refusal data for Supercomal Medical Products 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.