ImportRefusal LogoImportRefusal

Smile Phant Cosmetic Co.,

⚠️ Moderate Risk

FEI: 3007879839 • Bangkok • THAILAND

FEI

FEI Number

3007879839

📍

Location

Bangkok

🇹🇭

Country

THAILAND
🏢

Address

48/88 Vong Van Roadnok Road, , Bangkok, , Thailand

Moderate Risk

FDA Import Risk Assessment

36.4
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
9/25/2014
Latest Refusal
1/26/2010
Earliest Refusal

Score Breakdown

Violation Severity
76.7×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
4.3×10%
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

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).

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).

Refusal History

DateProductViolationsDivision
9/25/2014
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
1/26/2010
66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Smile Phant Cosmetic Co.,'s FDA import refusal history?

Smile Phant Cosmetic Co., (FEI: 3007879839) has 2 FDA import refusal record(s) in our database, spanning from 1/26/2010 to 9/25/2014.

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. Smile Phant Cosmetic Co.,'s FEI number is 3007879839.

What types of violations has Smile Phant Cosmetic Co., received?

Smile Phant Cosmetic Co., 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 Smile Phant Cosmetic Co., come from?

All FDA import refusal data for Smile Phant Cosmetic Co., 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.