ImportRefusal LogoImportRefusal

Rosee Cosmetic

⚠️ Moderate Risk

FEI: 3001245869 • Seoul • SOUTH KOREA

FEI

FEI Number

3001245869

📍

Location

Seoul

🇰🇷
🏢

Address

58723, , Seoul, , South Korea

Moderate Risk

FDA Import Risk Assessment

43.8
LowModerateHighCritical

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

Statistics

28
Total Refusals
2
Unique Violations
2/22/2010
Latest Refusal
7/9/2008
Earliest Refusal

Score Breakdown

Violation Severity
43.9×40%
Refusal Volume
54.2×30%
Recency
0.0×20%
Frequency
100.0×10%
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

47117×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

11811×

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
2/22/2010
66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)
2/22/2010
66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)
2/22/2010
66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)
2/22/2010
66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)
2/22/2010
66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)
2/22/2010
66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)
2/22/2010
66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)
1/13/2010
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
118NOT LISTED
Los Angeles District Office (LOS-DO)
12/23/2009
66PKL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
New York District Office (NYK-DO)
12/23/2009
66PJL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
New York District Office (NYK-DO)
12/23/2009
66PJL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
New York District Office (NYK-DO)
12/7/2009
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
New York District Office (NYK-DO)
12/7/2009
53GY99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
471CSTIC LBLG
New York District Office (NYK-DO)
12/7/2009
53GY99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
471CSTIC LBLG
New York District Office (NYK-DO)
12/7/2009
53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
New York District Office (NYK-DO)
12/7/2009
53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS)
471CSTIC LBLG
New York District Office (NYK-DO)
7/9/2008
53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
New York District Office (NYK-DO)
7/9/2008
53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
New York District Office (NYK-DO)
7/9/2008
53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
New York District Office (NYK-DO)
7/9/2008
53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
New York District Office (NYK-DO)
7/9/2008
53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
New York District Office (NYK-DO)
7/9/2008
53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
New York District Office (NYK-DO)
7/9/2008
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
New York District Office (NYK-DO)
7/9/2008
53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
471CSTIC LBLG
New York District Office (NYK-DO)
7/9/2008
53GY99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
471CSTIC LBLG
New York District Office (NYK-DO)
7/9/2008
53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
New York District Office (NYK-DO)
7/9/2008
53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
New York District Office (NYK-DO)
7/9/2008
53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
New York District Office (NYK-DO)

Frequently Asked Questions

What is Rosee Cosmetic's FDA import refusal history?

Rosee Cosmetic (FEI: 3001245869) has 28 FDA import refusal record(s) in our database, spanning from 7/9/2008 to 2/22/2010.

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. Rosee Cosmetic's FEI number is 3001245869.

What types of violations has Rosee Cosmetic received?

Rosee Cosmetic 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 Rosee Cosmetic come from?

All FDA import refusal data for Rosee Cosmetic 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.