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Minh Chau Medicine Store

⚠️ Moderate Risk

FEI: 3009844222 • Ho Chin Minh City • VIETNAM

FEI

FEI Number

3009844222

📍

Location

Ho Chin Minh City

🇻🇳

Country

VIETNAM
🏢

Address

663 Kha Van Can Street, , Ho Chin Minh City, , Vietnam

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
1/25/2013
Latest Refusal
1/25/2013
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

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).

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
1/25/2013
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Minh Chau Medicine Store's FDA import refusal history?

Minh Chau Medicine Store (FEI: 3009844222) has 1 FDA import refusal record(s) in our database, spanning from 1/25/2013 to 1/25/2013.

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. Minh Chau Medicine Store's FEI number is 3009844222.

What types of violations has Minh Chau Medicine Store received?

Minh Chau Medicine Store 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 Minh Chau Medicine Store come from?

All FDA import refusal data for Minh Chau Medicine Store 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.