SKIN1004
⚠️ Moderate Risk
FEI: 3027072102 • Seoul • SOUTH KOREA
FEI Number
3027072102
Location
Seoul
Country
SOUTH KOREAAddress
14 Milim Tower 12f, , 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/2/2024 | 66PAL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 10/2/2024 | 66PAL18ZINC OXIDE (ULTRAVIOLET SCREEN/SUNSCREEN) | Division of Southeast Imports (DSEI) | |
| 9/16/2024 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SKIN1004's FDA import refusal history?
SKIN1004 (FEI: 3027072102) has 3 FDA import refusal record(s) in our database, spanning from 9/16/2024 to 10/2/2024.
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. SKIN1004's FEI number is 3027072102.
What types of violations has SKIN1004 received?
SKIN1004 has been cited for 3 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 SKIN1004 come from?
All FDA import refusal data for SKIN1004 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.