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RESZON DIAGNOSTICS INTERNATIONAL SDN. BHD.

⚠️ Moderate Risk

FEI: 3012555859 • Shah Alam, Selangor • MALAYSIA

FEI

FEI Number

3012555859

📍

Location

Shah Alam, Selangor

🇲🇾

Country

MALAYSIA
🏢

Address

Revongen Corporation Center, Level 17, Top Glove Tower, Shah Alam, Selangor, Malaysia

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/29/2020
Latest Refusal
12/29/2020
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
12/29/2020
83QKOREAGENT, CORONAVIRUS SEROLOGICAL
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is RESZON DIAGNOSTICS INTERNATIONAL SDN. BHD.'s FDA import refusal history?

RESZON DIAGNOSTICS INTERNATIONAL SDN. BHD. (FEI: 3012555859) has 1 FDA import refusal record(s) in our database, spanning from 12/29/2020 to 12/29/2020.

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. RESZON DIAGNOSTICS INTERNATIONAL SDN. BHD.'s FEI number is 3012555859.

What types of violations has RESZON DIAGNOSTICS INTERNATIONAL SDN. BHD. received?

RESZON DIAGNOSTICS INTERNATIONAL 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 RESZON DIAGNOSTICS INTERNATIONAL SDN. BHD. come from?

All FDA import refusal data for RESZON DIAGNOSTICS INTERNATIONAL 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.