Choice Cosmetic Co., Ltd.
⚠️ Moderate Risk
FEI: 3013152320 • Cheonan, Chungcheongnam • SOUTH KOREA
FEI Number
3013152320
Location
Cheonan, Chungcheongnam
Country
SOUTH KOREAAddress
150, Pungsesandan-ro, Pungse-myeon, Dongnam-gu, Cheonan, Chungcheongnam, 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).
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.
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.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/20/2022 | 53AD02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | Division of Southeast Imports (DSEI) | |
| 7/12/2022 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 475COSMETLBLG | Division of Southeast Imports (DSEI) |
| 5/12/2022 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/10/2022 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Choice Cosmetic Co., Ltd.'s FDA import refusal history?
Choice Cosmetic Co., Ltd. (FEI: 3013152320) has 4 FDA import refusal record(s) in our database, spanning from 5/10/2022 to 9/20/2022.
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. Choice Cosmetic Co., Ltd.'s FEI number is 3013152320.
What types of violations has Choice Cosmetic Co., Ltd. received?
Choice Cosmetic Co., Ltd. has been cited for 5 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 Choice Cosmetic Co., Ltd. come from?
All FDA import refusal data for Choice Cosmetic 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.