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CONG TY CO PHAN MOI GIOI TM XNK

⚠️ Moderate Risk

FEI: 3012526493 • Ho Chi Minh • VIETNAM

FEI

FEI Number

3012526493

📍

Location

Ho Chi Minh

🇻🇳

Country

VIETNAM
🏢

Address

Binh Thanh District, 2, 29/17 D2 Street, Ward, Ho Chi Minh, , 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
65BCF01ACETYLCYSTEINE (MUCOLYTIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is CONG TY CO PHAN MOI GIOI TM XNK's FDA import refusal history?

CONG TY CO PHAN MOI GIOI TM XNK (FEI: 3012526493) 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 CO PHAN MOI GIOI TM XNK's FEI number is 3012526493.

What types of violations has CONG TY CO PHAN MOI GIOI TM XNK received?

CONG TY CO PHAN MOI GIOI TM XNK 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 CO PHAN MOI GIOI TM XNK come from?

All FDA import refusal data for CONG TY CO PHAN MOI GIOI TM XNK 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.