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Gen-Viet Tat Thanh Technology

⚠️ Moderate Risk

FEI: 3011777978 • Ho Chi Minh • VIETNAM

FEI

FEI Number

3011777978

📍

Location

Ho Chi Minh

🇻🇳

Country

VIETNAM
🏢

Address

320/18/24 Truong Chinh St., Ward 13 Tan, , Ho Chi Minh, , Vietnam

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
9/30/2015
Latest Refusal
9/30/2015
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
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

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

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
9/30/2015
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
333LACKS FIRM
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Gen-Viet Tat Thanh Technology's FDA import refusal history?

Gen-Viet Tat Thanh Technology (FEI: 3011777978) has 1 FDA import refusal record(s) in our database, spanning from 9/30/2015 to 9/30/2015.

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. Gen-Viet Tat Thanh Technology's FEI number is 3011777978.

What types of violations has Gen-Viet Tat Thanh Technology received?

Gen-Viet Tat Thanh Technology 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 Gen-Viet Tat Thanh Technology come from?

All FDA import refusal data for Gen-Viet Tat Thanh Technology 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.