Soleo Cosmetic CO.,LTD
⚠️ Moderate Risk
FEI: 3009699696 • Pyeongtaek, Gyeonggi • SOUTH KOREA
FEI Number
3009699696
Location
Pyeongtaek, Gyeonggi
Country
SOUTH KOREAAddress
24 Sandan-ro, , Pyeongtaek, Gyeonggi, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
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.
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 |
|---|---|---|---|
| 11/12/2020 | 62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) | |
| 9/30/2020 | 62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 8/26/2020 | 62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 8/14/2020 | 62HAL99ANTI-MICROBIAL N.E.C. | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 8/14/2020 | 62HAL99ANTI-MICROBIAL N.E.C. | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 8/14/2020 | 62HAL99ANTI-MICROBIAL N.E.C. | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 6/17/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 6/12/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of West Coast Imports (DWCI) | |
| 5/20/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 5/20/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 4/14/2020 | 62FAN99ANTI-INFECTIVE, TOPICAL N.E.C. | 472NO ENGLISH | Division of Southeast Imports (DSEI) |
| 4/14/2020 | 62FAN99ANTI-INFECTIVE, TOPICAL N.E.C. | 472NO ENGLISH | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Soleo Cosmetic CO.,LTD's FDA import refusal history?
Soleo Cosmetic CO.,LTD (FEI: 3009699696) has 12 FDA import refusal record(s) in our database, spanning from 4/14/2020 to 11/12/2020.
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. Soleo Cosmetic CO.,LTD's FEI number is 3009699696.
What types of violations has Soleo Cosmetic CO.,LTD received?
Soleo 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 Soleo Cosmetic CO.,LTD come from?
All FDA import refusal data for Soleo 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.