TONYMOLY Co., Ltd.
⚠️ High Risk
FEI: 3011569103 • Seoco-gu, Seoulteugbyeol-si • SOUTH KOREA
FEI Number
3011569103
Location
Seoco-gu, Seoulteugbyeol-si
Country
SOUTH KOREAAddress
180 Bangbae-ro, , Seoco-gu, Seoulteugbyeol-si, South Korea
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
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.
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.
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).
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).
HELD INSAN
The cosmetic appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
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).
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 |
|---|---|---|---|
| 10/4/2023 | 53CY99OTHER EYE MAKEUP PREPARATIONS, N.E.C. | 310POISONOUS | Division of West Coast Imports (DWCI) |
| 1/16/2019 | 53CI99OTHER EYE MAKEUP PREPARATIONS, N.E.C. | 471CSTIC LBLG | Division of West Coast Imports (DWCI) |
| 1/16/2019 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 8/21/2017 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 5/9/2017 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 12/21/2016 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of Northeast Imports (DNEI) | |
| 12/21/2016 | 53CF99OTHER EYE MAKEUP PREPARATIONS, N.E.C. | Division of Northeast Imports (DNEI) | |
| 7/13/2016 | 53CY04EYE LOTION (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Division of Southeast Imports (DSEI) |
| 6/23/2016 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 5/18/2016 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Cincinnati District Office (CIN-DO) | |
| 5/18/2016 | 53CY99OTHER EYE MAKEUP PREPARATIONS, N.E.C. | 310POISONOUS | Cincinnati District Office (CIN-DO) |
| 4/20/2016 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Cincinnati District Office (CIN-DO) | |
| 2/8/2016 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 475COSMETLBLG | Cincinnati District Office (CIN-DO) |
| 2/8/2016 | 53LY06MOISTURIZING (SKIN CARE PREPARATIONS) | Cincinnati District Office (CIN-DO) | |
| 11/13/2015 | 53LY09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 5/16/2014 | 53CF99OTHER EYE MAKEUP PREPARATIONS, N.E.C. | 310POISONOUS | Seattle District Office (SEA-DO) |
| 8/9/2012 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is TONYMOLY Co., Ltd.'s FDA import refusal history?
TONYMOLY Co., Ltd. (FEI: 3011569103) has 17 FDA import refusal record(s) in our database, spanning from 8/9/2012 to 10/4/2023.
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. TONYMOLY Co., Ltd.'s FEI number is 3011569103.
What types of violations has TONYMOLY Co., Ltd. received?
TONYMOLY 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 TONYMOLY Co., Ltd. come from?
All FDA import refusal data for TONYMOLY 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.