Skin79 Co., Ltd.
⚠️ Moderate Risk
FEI: 3009051182 • Yeongdeungpo-gu, Seoulteugbyeol-si • SOUTH KOREA
FEI Number
3009051182
Location
Yeongdeungpo-gu, Seoulteugbyeol-si
Country
SOUTH KOREAAddress
97 Yisadangdae-ro, , Yeongdeungpo-gu, Seoulteugbyeol-si, 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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/28/2013 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New Orleans District Office (NOL-DO) | |
| 1/28/2013 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New Orleans District Office (NOL-DO) | |
| 11/23/2012 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 11/23/2012 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 11/23/2012 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 6/17/2010 | 53GD03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 475COSMETLBLG | Los Angeles District Office (LOS-DO) |
| 6/17/2010 | 53GD03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 475COSMETLBLG | Los Angeles District Office (LOS-DO) |
| 12/14/2009 | 53GH02FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) | 473LABELING | Los Angeles District Office (LOS-DO) |
| 12/14/2009 | 53GY05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 473LABELING | Los Angeles District Office (LOS-DO) |
| 12/14/2009 | 53LC08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 473LABELING | Los Angeles District Office (LOS-DO) |
| 12/14/2009 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 473LABELING | Los Angeles District Office (LOS-DO) |
| 12/14/2009 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 473LABELING | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Skin79 Co., Ltd.'s FDA import refusal history?
Skin79 Co., Ltd. (FEI: 3009051182) has 12 FDA import refusal record(s) in our database, spanning from 12/14/2009 to 1/28/2013.
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. Skin79 Co., Ltd.'s FEI number is 3009051182.
What types of violations has Skin79 Co., Ltd. received?
Skin79 Co., Ltd. has been cited for 8 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 Skin79 Co., Ltd. come from?
All FDA import refusal data for Skin79 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.