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Oon Corp Resources M Sdn Bhd

✅ Low Risk

FEI: 3008589005 • Dural Khusus • MALAYSIA

FEI

FEI Number

3008589005

📍

Location

Dural Khusus

🇲🇾

Country

MALAYSIA
🏢

Address

59 Senawang Ind Est, , Dural Khusus, , Malaysia

Low Risk

FDA Import Risk Assessment

23.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
11/9/2010
Latest Refusal
11/9/2010
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

3414×

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
11/9/2010
80LYYGLOVE, PATIENT EXAMINATION, LATEX
341REGISTERED
New York District Office (NYK-DO)
11/9/2010
80LYYGLOVE, PATIENT EXAMINATION, LATEX
341REGISTERED
New York District Office (NYK-DO)
11/9/2010
80LYYGLOVE, PATIENT EXAMINATION, LATEX
341REGISTERED
New York District Office (NYK-DO)
11/9/2010
80LYYGLOVE, PATIENT EXAMINATION, LATEX
341REGISTERED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Oon Corp Resources M Sdn Bhd's FDA import refusal history?

Oon Corp Resources M Sdn Bhd (FEI: 3008589005) has 4 FDA import refusal record(s) in our database, spanning from 11/9/2010 to 11/9/2010.

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. Oon Corp Resources M Sdn Bhd's FEI number is 3008589005.

What types of violations has Oon Corp Resources M Sdn Bhd received?

Oon Corp Resources M 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 Oon Corp Resources M Sdn Bhd come from?

All FDA import refusal data for Oon Corp Resources M 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.