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KHAU TRANG KHANG KHUAN

⚠️ Moderate Risk

FEI: 3017076488 • Thanh • VIETNAM

FEI

FEI Number

3017076488

📍

Location

Thanh

🇻🇳

Country

VIETNAM
🏢

Address

Cong Ty Tnhh San Xuat T, , Thanh, , Vietnam

Moderate Risk

FDA Import Risk Assessment

34.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
9/4/2020
Latest Refusal
9/4/2020
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
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

2371×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

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
9/4/2020
80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE
237NO PMA
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is KHAU TRANG KHANG KHUAN's FDA import refusal history?

KHAU TRANG KHANG KHUAN (FEI: 3017076488) has 1 FDA import refusal record(s) in our database, spanning from 9/4/2020 to 9/4/2020.

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. KHAU TRANG KHANG KHUAN's FEI number is 3017076488.

What types of violations has KHAU TRANG KHANG KHUAN received?

KHAU TRANG KHANG KHUAN 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 KHAU TRANG KHANG KHUAN come from?

All FDA import refusal data for KHAU TRANG KHANG KHUAN 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.