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CONG TY TNHH THUY SAN CHANGHUA VIETNAM

⚠️ Moderate Risk

FEI: 2000032586 • Vung Tau, Ba Ria-Vung Tau • VIETNAM

FEI

FEI Number

2000032586

📍

Location

Vung Tau, Ba Ria-Vung Tau

🇻🇳

Country

VIETNAM
🏢

Address

Vung Tau City, 04, Trung Trac; Phuong 1, Vung Tau, Ba Ria-Vung Tau, Vietnam

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
1/5/2021
Latest Refusal
1/5/2021
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
1/5/2021
61ECE08LORATADINE (ANTI-ASTHMATIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is CONG TY TNHH THUY SAN CHANGHUA VIETNAM's FDA import refusal history?

CONG TY TNHH THUY SAN CHANGHUA VIETNAM (FEI: 2000032586) has 1 FDA import refusal record(s) in our database, spanning from 1/5/2021 to 1/5/2021.

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. CONG TY TNHH THUY SAN CHANGHUA VIETNAM's FEI number is 2000032586.

What types of violations has CONG TY TNHH THUY SAN CHANGHUA VIETNAM received?

CONG TY TNHH THUY SAN CHANGHUA VIETNAM 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 CONG TY TNHH THUY SAN CHANGHUA VIETNAM come from?

All FDA import refusal data for CONG TY TNHH THUY SAN CHANGHUA VIETNAM 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.