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Rosee Cosmetics Co.

⚠️ Moderate Risk

FEI: 3003209009 • Seoul • SOUTH KOREA

FEI

FEI Number

3003209009

📍

Location

Seoul

🇰🇷
🏢

Address

100-29 Sinseol-Dongdongdaemun-Gu,, , Seoul, , South Korea

Moderate Risk

FDA Import Risk Assessment

37.1
LowModerateHighCritical

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

Statistics

9
Total Refusals
2
Unique Violations
3/2/2004
Latest Refusal
3/2/2004
Earliest Refusal

Score Breakdown

Violation Severity
42.5×40%
Refusal Volume
37.0×30%
Recency
0.0×20%
Frequency
90.0×10%
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

4719×

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.

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).

Refusal History

DateProductViolationsDivision
3/2/2004
53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
471CSTIC LBLG
Baltimore District Office (BLT-DO)
3/2/2004
53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
471CSTIC LBLG
Baltimore District Office (BLT-DO)
3/2/2004
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Baltimore District Office (BLT-DO)
3/2/2004
53GC03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES)
471CSTIC LBLG
Baltimore District Office (BLT-DO)
3/2/2004
53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Baltimore District Office (BLT-DO)
3/2/2004
53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
471CSTIC LBLG
Baltimore District Office (BLT-DO)
3/2/2004
53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS)
118NOT LISTED
471CSTIC LBLG
Baltimore District Office (BLT-DO)
3/2/2004
53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS)
118NOT LISTED
471CSTIC LBLG
Baltimore District Office (BLT-DO)
3/2/2004
53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS)
118NOT LISTED
471CSTIC LBLG
Baltimore District Office (BLT-DO)

Frequently Asked Questions

What is Rosee Cosmetics Co.'s FDA import refusal history?

Rosee Cosmetics Co. (FEI: 3003209009) has 9 FDA import refusal record(s) in our database, spanning from 3/2/2004 to 3/2/2004.

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 Cosmetics Co.'s FEI number is 3003209009.

What types of violations has Rosee Cosmetics Co. received?

Rosee Cosmetics 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 Rosee Cosmetics Co. come from?

All FDA import refusal data for Rosee Cosmetics 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.