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VIET XUAN COMPANY

⚠️ Moderate Risk

FEI: 3017088144 • Ho Chi Minh Ci • VIETNAM

FEI

FEI Number

3017088144

📍

Location

Ho Chi Minh Ci

🇻🇳

Country

VIETNAM
🏢

Address

No 65, Le Due Tho St War, , Ho Chi Minh Ci, , Vietnam

Moderate Risk

FDA Import Risk Assessment

36.6
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
6/13/2024
Latest Refusal
6/13/2024
Earliest Refusal

Score Breakdown

Violation Severity
46.7×40%
Refusal Volume
11.2×30%
Recency
68.0×20%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

4711×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

Refusal History

DateProductViolationsDivision
6/13/2024
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
118NOT LISTED
3280FRNMFGREG
471CSTIC LBLG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is VIET XUAN COMPANY's FDA import refusal history?

VIET XUAN COMPANY (FEI: 3017088144) has 1 FDA import refusal record(s) in our database, spanning from 6/13/2024 to 6/13/2024.

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. VIET XUAN COMPANY's FEI number is 3017088144.

What types of violations has VIET XUAN COMPANY received?

VIET XUAN COMPANY has been cited for 3 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 VIET XUAN COMPANY come from?

All FDA import refusal data for VIET XUAN COMPANY 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.