The FaceShop Co., Ltd.
⚠️ Moderate Risk
FEI: 3010164333 • Seoul, Seoul • SOUTH KOREA
FEI Number
3010164333
Location
Seoul, Seoul
Country
SOUTH KOREAAddress
58 Saemunan-Ro, Jongno-Gu, , Seoul, 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).
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.
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
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 |
|---|---|---|---|
| 6/21/2019 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/21/2015 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/21/2015 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/21/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/21/2015 | 65L11TITANIUM DIOXIDE (PROTECTANT) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 12/10/2014 | 53UC12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OTHER ANIMAL BY-PRODUCTS) | 197COSM COLOR | Philadelphia District Office (PHI-DO) |
| 12/10/2014 | 53UC12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OTHER ANIMAL BY-PRODUCTS) | 197COSM COLOR | Philadelphia District Office (PHI-DO) |
| 12/10/2014 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Philadelphia District Office (PHI-DO) | |
| 12/10/2014 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Philadelphia District Office (PHI-DO) | |
| 12/10/2014 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Philadelphia District Office (PHI-DO) | |
| 12/10/2014 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Philadelphia District Office (PHI-DO) | |
| 12/10/2014 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Philadelphia District Office (PHI-DO) | |
| 10/1/2009 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
| 10/1/2009 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
| 10/1/2009 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
| 10/1/2009 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
| 10/1/2009 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
| 10/1/2009 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
| 10/1/2009 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
| 10/1/2009 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
| 10/1/2009 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
| 10/1/2009 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
| 10/1/2009 | 53LF08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
| 10/1/2009 | 53GH01BLUSHERS (ALL TYPES) (MAKEUP PREPARATIONS, NOT FOR EYES) | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
| 10/1/2009 | 53GD05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
| 10/1/2009 | 63VBJ99DEPIGMENTOR N.E.C. | San Francisco District Office (SAN-DO) | |
| 8/24/2009 | 53GD05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | San Francisco District Office (SAN-DO) |
| 8/24/2009 | 53GD05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | San Francisco District Office (SAN-DO) |
| 8/24/2009 | 53GD05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | San Francisco District Office (SAN-DO) |
| 8/24/2009 | 53GD05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | San Francisco District Office (SAN-DO) |
| 8/24/2009 | 53GD05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | San Francisco District Office (SAN-DO) |
| 8/24/2009 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 8/24/2009 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 8/24/2009 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 8/24/2009 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 8/24/2009 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 8/24/2009 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 8/24/2009 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 8/24/2009 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is The FaceShop Co., Ltd.'s FDA import refusal history?
The FaceShop Co., Ltd. (FEI: 3010164333) has 39 FDA import refusal record(s) in our database, spanning from 8/24/2009 to 6/21/2019.
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. The FaceShop Co., Ltd.'s FEI number is 3010164333.
What types of violations has The FaceShop Co., Ltd. received?
The FaceShop Co., Ltd. has been cited for 7 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 The FaceShop Co., Ltd. come from?
All FDA import refusal data for The FaceShop 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.