Missha
⚠️ Moderate Risk
FEI: 3009635503 • Seoul • SOUTH KOREA
FEI Number
3009635503
Location
Seoul
Country
SOUTH KOREAAddress
83 Doryeomdong, Jongro-Gu, , Seoul, , South Korea
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/26/2012 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 7/26/2012 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 7/26/2012 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 7/26/2012 | 53GH02FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) | Seattle District Office (SEA-DO) | |
| 7/26/2012 | 53GH02FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) | Seattle District Office (SEA-DO) | |
| 7/26/2012 | 53GH02FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Missha's FDA import refusal history?
Missha (FEI: 3009635503) has 6 FDA import refusal record(s) in our database, spanning from 7/26/2012 to 7/26/2012.
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. Missha's FEI number is 3009635503.
What types of violations has Missha received?
Missha 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 Missha come from?
All FDA import refusal data for Missha 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.