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KHUN DUANGJAI

⚠️ Moderate Risk

FEI: 3021509723 • Bangkok • THAILAND

FEI

FEI Number

3021509723

📍

Location

Bangkok

🇹🇭

Country

THAILAND
🏢

Address

12/58 Ruamsuk Condomini, , Bangkok, , Thailand

Moderate Risk

FDA Import Risk Assessment

33.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
2/15/2022
Latest Refusal
2/15/2022
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
7.9×20%
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
2/15/2022
83QKOREAGENT, CORONAVIRUS SEROLOGICAL
508NO 510(K)
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is KHUN DUANGJAI's FDA import refusal history?

KHUN DUANGJAI (FEI: 3021509723) has 1 FDA import refusal record(s) in our database, spanning from 2/15/2022 to 2/15/2022.

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. KHUN DUANGJAI's FEI number is 3021509723.

What types of violations has KHUN DUANGJAI received?

KHUN DUANGJAI 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 KHUN DUANGJAI come from?

All FDA import refusal data for KHUN DUANGJAI 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.