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World Wide Agent Universe Beauty

⚠️ Moderate Risk

FEI: 3009426378 • Bangkok • THAILAND

FEI

FEI Number

3009426378

📍

Location

Bangkok

🇹🇭

Country

THAILAND
🏢

Address

1095-1101 Charoen Krung Road, , Bangkok, , Thailand

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
4/25/2012
Latest Refusal
4/25/2012
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1182×

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).

752×

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
4/25/2012
66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
San Francisco District Office (SAN-DO)
4/25/2012
66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is World Wide Agent Universe Beauty's FDA import refusal history?

World Wide Agent Universe Beauty (FEI: 3009426378) has 2 FDA import refusal record(s) in our database, spanning from 4/25/2012 to 4/25/2012.

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. World Wide Agent Universe Beauty's FEI number is 3009426378.

What types of violations has World Wide Agent Universe Beauty received?

World Wide Agent Universe Beauty 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 World Wide Agent Universe Beauty come from?

All FDA import refusal data for World Wide Agent Universe Beauty 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.