SILICONTWO
⚠️ High Risk
FEI: 3012484196 • SEONGNAM • SOUTH KOREA
FEI Number
3012484196
Location
SEONGNAM
Country
SOUTH KOREAAddress
680 SAMPYEONG DONG BUND, , SEONGNAM, , South Korea
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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 |
|---|---|---|---|
| 3/13/2017 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Division of West Coast Imports (DWCI) |
| 3/13/2017 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Division of West Coast Imports (DWCI) |
| 3/13/2017 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 3/13/2017 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 3/13/2017 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 3/13/2017 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 3/13/2017 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 3/13/2017 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 3/13/2017 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 3/13/2017 | 53LH99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 3/13/2017 | 53LH99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 3/13/2017 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 3/13/2017 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 3/13/2017 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 3/13/2017 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 3/13/2017 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is SILICONTWO's FDA import refusal history?
SILICONTWO (FEI: 3012484196) has 16 FDA import refusal record(s) in our database, spanning from 3/13/2017 to 3/13/2017.
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. SILICONTWO's FEI number is 3012484196.
What types of violations has SILICONTWO received?
SILICONTWO 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 SILICONTWO come from?
All FDA import refusal data for SILICONTWO 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.