ImportRefusal LogoImportRefusal

Ming Fai Enterprise (Cambodia) Co., Ltd.

⚠️ Moderate Risk

FEI: 3015531959 • Kampong Speu, Kampong Speu • CAMBODIA

FEI

FEI Number

3015531959

📍

Location

Kampong Speu, Kampong Speu

🇰🇭

Country

CAMBODIA
🏢

Address

National Road 41(Preah Ang Duong Road), Veal Vong Village, Sen Dei Commune, Somroung Tong,, Kampong Speu, Kampong Speu, Cambodia

Moderate Risk

FDA Import Risk Assessment

30.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/4/2024
Latest Refusal
9/4/2024
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
73.0×20%
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

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
9/4/2024
76EFWTOOTHBRUSH, MANUAL
341REGISTERED
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is Ming Fai Enterprise (Cambodia) Co., Ltd.'s FDA import refusal history?

Ming Fai Enterprise (Cambodia) Co., Ltd. (FEI: 3015531959) has 1 FDA import refusal record(s) in our database, spanning from 9/4/2024 to 9/4/2024.

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. Ming Fai Enterprise (Cambodia) Co., Ltd.'s FEI number is 3015531959.

What types of violations has Ming Fai Enterprise (Cambodia) Co., Ltd. received?

Ming Fai Enterprise (Cambodia) Co., Ltd. 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 Ming Fai Enterprise (Cambodia) Co., Ltd. come from?

All FDA import refusal data for Ming Fai Enterprise (Cambodia) Co., Ltd. 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.