Tonlymoly Co Ltd
⚠️ Moderate Risk
FEI: 3010225115 • Seocho Gu • SOUTH KOREA
FEI Number
3010225115
Location
Seocho Gu
Country
SOUTH KOREAAddress
Tonymoly B/D 851-3, , Seocho Gu, , 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).
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/18/2017 | 64XBY06SALICYLIC ACID (KERATOLYTIC) | Division of West Coast Imports (DWCI) | |
| 6/1/2016 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 475COSMETLBLG | Seattle District Office (SEA-DO) |
| 6/1/2016 | 53CK04EYE LOTION (EYE MAKEUP PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 12/16/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of Northeast Imports (DNEI) | |
| 12/16/2015 | 53CC02EYELINER (EYE MAKEUP PREPARATIONS) | Division of Northeast Imports (DNEI) | |
| 12/16/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 12/16/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 12/16/2015 | 53GC99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 12/16/2015 | 53GC99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 12/16/2015 | 53GC99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 3/17/2015 | 65LAY99PROTECTANT N.E.C. | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Tonlymoly Co Ltd's FDA import refusal history?
Tonlymoly Co Ltd (FEI: 3010225115) has 11 FDA import refusal record(s) in our database, spanning from 3/17/2015 to 5/18/2017.
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. Tonlymoly Co Ltd's FEI number is 3010225115.
What types of violations has Tonlymoly Co Ltd received?
Tonlymoly 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 Tonlymoly Co Ltd come from?
All FDA import refusal data for Tonlymoly 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.