ImportRefusal LogoImportRefusal

Komar Cosmetics (Guangzhou) Ltd

⚠️ Moderate Risk

FEI: 3005564376 • Guangzhou, Guangdong • CHINA

FEI

FEI Number

3005564376

📍

Location

Guangzhou, Guangdong

🇨🇳

Country

CHINA
🏢

Address

48 Hongmian Road, Huadu Xinhua Town, , Guangzhou, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
4
Unique Violations
6/13/2012
Latest Refusal
6/13/2012
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

30001×

N-RX INACT

The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.

3361×

INCONSPICU

Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

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
6/13/2012
66VBK99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
3000N-RX INACT
336INCONSPICU
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Komar Cosmetics (Guangzhou) Ltd's FDA import refusal history?

Komar Cosmetics (Guangzhou) Ltd (FEI: 3005564376) has 1 FDA import refusal record(s) in our database, spanning from 6/13/2012 to 6/13/2012.

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. Komar Cosmetics (Guangzhou) Ltd's FEI number is 3005564376.

What types of violations has Komar Cosmetics (Guangzhou) Ltd received?

Komar Cosmetics (Guangzhou) Ltd has been cited for 4 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 Komar Cosmetics (Guangzhou) Ltd come from?

All FDA import refusal data for Komar Cosmetics (Guangzhou) 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.