Etude House
⚠️ Moderate Risk
FEI: 3008645760 • Seoul, Seoul • SOUTH KOREA
FEI Number
3008645760
Location
Seoul, Seoul
Country
SOUTH KOREAAddress
Myonmok 7 Dong 2 9a, , Seoul, 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
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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/9/2012 | 53BY99OTHER BATH PREPARATIONS, N.E.C. | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 8/9/2012 | 53BY99OTHER BATH PREPARATIONS, N.E.C. | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 8/9/2012 | 53BY99OTHER BATH PREPARATIONS, N.E.C. | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 8/9/2012 | 53BY99OTHER BATH PREPARATIONS, N.E.C. | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 8/9/2012 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Etude House's FDA import refusal history?
Etude House (FEI: 3008645760) has 5 FDA import refusal record(s) in our database, spanning from 8/9/2012 to 8/9/2012.
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. Etude House's FEI number is 3008645760.
What types of violations has Etude House received?
Etude House 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 Etude House come from?
All FDA import refusal data for Etude House 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.