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HOA TRA COSMETICS CO LTD

⚠️ Moderate Risk

FEI: 3032910776 • Long Xuyen • VIETNAM

FEI

FEI Number

3032910776

📍

Location

Long Xuyen

🇻🇳

Country

VIETNAM
🏢

Address

8, Tran Hung Dao St Binh, , Long Xuyen, , Vietnam

Moderate Risk

FDA Import Risk Assessment

44.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
12/23/2024
Latest Refusal
12/23/2024
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
78.7×20%
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

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

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
12/23/2024
66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
472NO ENGLISH
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is HOA TRA COSMETICS CO LTD's FDA import refusal history?

HOA TRA COSMETICS CO LTD (FEI: 3032910776) has 1 FDA import refusal record(s) in our database, spanning from 12/23/2024 to 12/23/2024.

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. HOA TRA COSMETICS CO LTD's FEI number is 3032910776.

What types of violations has HOA TRA COSMETICS CO LTD received?

HOA TRA COSMETICS CO LTD 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 HOA TRA COSMETICS CO LTD come from?

All FDA import refusal data for HOA TRA COSMETICS CO LTD 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.