ImportRefusal LogoImportRefusal

Generate Nation Soap Cosmetics

⚠️ Moderate Risk

FEI: 3005038758 • Bangkok • THAILAND

FEI

FEI Number

3005038758

📍

Location

Bangkok

🇹🇭

Country

THAILAND
🏢

Address

681/17 Soi Charansanidwong, , Bangkok, , Thailand

Moderate Risk

FDA Import Risk Assessment

32.0
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
5/25/2011
Latest Refusal
11/25/2009
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
13.4×10%
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).

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
5/25/2011
53JL01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
11/25/2009
53DH03POWDERS (DUSTING AND TALCUM, EXCLUDING AFTERSHAVE TALC) (FRAGRANCE PREPARATIONS)
118NOT LISTED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Generate Nation Soap Cosmetics's FDA import refusal history?

Generate Nation Soap Cosmetics (FEI: 3005038758) has 2 FDA import refusal record(s) in our database, spanning from 11/25/2009 to 5/25/2011.

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. Generate Nation Soap Cosmetics's FEI number is 3005038758.

What types of violations has Generate Nation Soap Cosmetics received?

Generate Nation Soap Cosmetics 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 Generate Nation Soap Cosmetics come from?

All FDA import refusal data for Generate Nation Soap Cosmetics 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.