Lioele Cosmetic Co., Ltd.
⚠️ Moderate Risk
FEI: 3010166808 • Busan • SOUTH KOREA
FEI Number
3010166808
Location
Busan
Country
SOUTH KOREAAddress
5F, Sugwang Bldg., 24-13, Namsan-dong, G, , Busan, , 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).
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).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
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.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/2/2016 | 50NHY18HENNA | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 4/30/2014 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/6/2013 | 66PAY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Chicago District Office (CHI-DO) | |
| 10/10/2011 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/10/2011 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/10/2011 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/2/2011 | 53CK99OTHER EYE MAKEUP PREPARATIONS, N.E.C. | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
| 6/2/2011 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 6/2/2011 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 11/29/2010 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Baltimore District Office (BLT-DO) | |
| 11/29/2010 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Lioele Cosmetic Co., Ltd.'s FDA import refusal history?
Lioele Cosmetic Co., Ltd. (FEI: 3010166808) has 11 FDA import refusal record(s) in our database, spanning from 11/29/2010 to 8/2/2016.
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. Lioele Cosmetic Co., Ltd.'s FEI number is 3010166808.
What types of violations has Lioele Cosmetic Co., Ltd. received?
Lioele Cosmetic Co., Ltd. has been cited for 9 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 Lioele Cosmetic Co., Ltd. come from?
All FDA import refusal data for Lioele 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.