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Shaan Honq Int'L Cosmetics Corp

⚠️ Moderate Risk

FEI: 3004996396 • Kaohsiung • TAIWAN

FEI

FEI Number

3004996396

📍

Location

Kaohsiung

🇹🇼

Country

TAIWAN
🏢

Address

29f, No.55 Chung Cheng 3 Rd., Hsin Hsing, , Kaohsiung, , Taiwan

Moderate Risk

FDA Import Risk Assessment

37.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
2/3/2012
Latest Refusal
2/3/2012
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

1183×

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).

753×

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
2/3/2012
53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/3/2012
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/3/2012
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Shaan Honq Int'L Cosmetics Corp's FDA import refusal history?

Shaan Honq Int'L Cosmetics Corp (FEI: 3004996396) has 3 FDA import refusal record(s) in our database, spanning from 2/3/2012 to 2/3/2012.

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. Shaan Honq Int'L Cosmetics Corp's FEI number is 3004996396.

What types of violations has Shaan Honq Int'L Cosmetics Corp received?

Shaan Honq Int'L Cosmetics Corp 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 Shaan Honq Int'L Cosmetics Corp come from?

All FDA import refusal data for Shaan Honq Int'L Cosmetics Corp 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.