Somang Cosmetics Co Ltd
⚠️ Moderate Risk
FEI: 3003579980 • Inchon City • SOUTH KOREA
FEI Number
3003579980
Location
Inchon City
Country
SOUTH KOREAAddress
68714 Kojandong Namdongku, , Inchon City, , 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 |
|---|---|---|---|
| 2/14/2012 | 53EC03HAIR STRAIGHTENERS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 2/14/2012 | 53EC04PERMANENT WAVES (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 2/14/2012 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 2/14/2012 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 7/30/2008 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 7/30/2008 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 7/30/2008 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 7/30/2008 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Somang Cosmetics Co Ltd's FDA import refusal history?
Somang Cosmetics Co Ltd (FEI: 3003579980) has 8 FDA import refusal record(s) in our database, spanning from 7/30/2008 to 2/14/2012.
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. Somang Cosmetics Co Ltd's FEI number is 3003579980.
What types of violations has Somang Cosmetics Co Ltd received?
Somang Cosmetics Co Ltd 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 Somang Cosmetics Co Ltd come from?
All FDA import refusal data for Somang Cosmetics Co Ltd 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.