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ITG Electronics (Malaysia) Sdn Bhd

✅ Low Risk

FEI: 3003517662 • Johor Bahru, Johor • MALAYSIA

FEI

FEI Number

3003517662

📍

Location

Johor Bahru, Johor

🇲🇾

Country

MALAYSIA
🏢

Address

No 3 & 10 Jalan Hasil, , Johor Bahru, Johor, Malaysia

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
11/9/2001
Latest Refusal
11/9/2001
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
11/9/2001
80LRJDISINFECTANT, MEDICAL DEVICES
118NOT LISTED
341REGISTERED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is ITG Electronics (Malaysia) Sdn Bhd's FDA import refusal history?

ITG Electronics (Malaysia) Sdn Bhd (FEI: 3003517662) has 1 FDA import refusal record(s) in our database, spanning from 11/9/2001 to 11/9/2001.

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. ITG Electronics (Malaysia) Sdn Bhd's FEI number is 3003517662.

What types of violations has ITG Electronics (Malaysia) Sdn Bhd received?

ITG Electronics (Malaysia) Sdn Bhd has been cited for 2 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 ITG Electronics (Malaysia) Sdn Bhd come from?

All FDA import refusal data for ITG Electronics (Malaysia) 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.