Innisfree
⚠️ Moderate Risk
FEI: 3010985868 • Seoul • SOUTH KOREA
FEI Number
3010985868
Location
Seoul
Country
SOUTH KOREAAddress
6f Signiture Tower 100 Cheonggyecheon Ro, , 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
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).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/17/2018 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Northeast Imports (DNEI) | |
| 8/10/2018 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 5/23/2018 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Innisfree's FDA import refusal history?
Innisfree (FEI: 3010985868) has 3 FDA import refusal record(s) in our database, spanning from 5/23/2018 to 8/17/2018.
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. Innisfree's FEI number is 3010985868.
What types of violations has Innisfree received?
Innisfree 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 Innisfree come from?
All FDA import refusal data for Innisfree 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.