COSON Co., Ltd. _Osan Plant
⚠️ Moderate Risk
FEI: 3010164718 • Osan, Gyeonggi • SOUTH KOREA
FEI Number
3010164718
Location
Osan, Gyeonggi
Country
SOUTH KOREAAddress
40-20 Gajangsaneopseobuk-Ro, , Osan, 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
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/20/2021 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Division of West Coast Imports (DWCI) |
| 1/20/2021 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Division of West Coast Imports (DWCI) |
| 1/20/2021 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of West Coast Imports (DWCI) |
| 8/30/2019 | 66PBL18ZINC OXIDE (ULTRAVIOLET SCREEN/SUNSCREEN) | 336INCONSPICU | Division of West Coast Imports (DWCI) |
| 8/30/2019 | 66PBL18ZINC OXIDE (ULTRAVIOLET SCREEN/SUNSCREEN) | 336INCONSPICU | Division of West Coast Imports (DWCI) |
| 8/16/2019 | 66PBL18ZINC OXIDE (ULTRAVIOLET SCREEN/SUNSCREEN) | Division of West Coast Imports (DWCI) | |
| 12/29/2017 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 472NO ENGLISH | Division of Southeast Imports (DSEI) |
| 9/2/2016 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is COSON Co., Ltd. _Osan Plant's FDA import refusal history?
COSON Co., Ltd. _Osan Plant (FEI: 3010164718) has 8 FDA import refusal record(s) in our database, spanning from 9/2/2016 to 1/20/2021.
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. COSON Co., Ltd. _Osan Plant's FEI number is 3010164718.
What types of violations has COSON Co., Ltd. _Osan Plant received?
COSON Co., Ltd. _Osan Plant has been cited for 6 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 COSON Co., Ltd. _Osan Plant come from?
All FDA import refusal data for COSON Co., Ltd. _Osan Plant 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.