The Face Shop Co Ltd
⚠️ Moderate Risk
FEI: 3008808022 • Seoul • SOUTH KOREA
FEI Number
3008808022
Location
Seoul
Country
SOUTH KOREAAddress
92 Sinmunno 2ga, , 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).
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.
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.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 |
|---|---|---|---|
| 10/16/2015 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/29/2015 | 65L11TITANIUM DIOXIDE (PROTECTANT) | Los Angeles District Office (LOS-DO) | |
| 12/24/2014 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Cincinnati District Office (CIN-DO) | |
| 12/24/2014 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Cincinnati District Office (CIN-DO) | |
| 3/29/2012 | 65LB11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 3/29/2012 | 65LB11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 3/29/2012 | 65LB11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 3/29/2012 | 65LJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 3/29/2012 | 65LJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 3/29/2012 | 65LB11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 3/29/2012 | 65LB11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 3/29/2012 | 65LB11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 12/5/2011 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
| 12/5/2011 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
| 12/5/2011 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
| 12/5/2011 | 66VCJ99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 12/5/2011 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 12/5/2011 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 12/5/2011 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is The Face Shop Co Ltd's FDA import refusal history?
The Face Shop Co Ltd (FEI: 3008808022) has 19 FDA import refusal record(s) in our database, spanning from 12/5/2011 to 10/16/2015.
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 Face Shop Co Ltd's FEI number is 3008808022.
What types of violations has The Face Shop Co Ltd received?
The Face Shop Co Ltd has been cited for 6 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 Face Shop Co Ltd come from?
All FDA import refusal data for The Face Shop 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.