Eyesome Co., Ltd.
⚠️ Moderate Risk
FEI: 3010235400 • Anseong, Gyeonggi • SOUTH KOREA
FEI Number
3010235400
Location
Anseong, Gyeonggi
Country
SOUTH KOREAAddress
309 Gieopdanji-Ro, Wongong-Myeon, Anseong, 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
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).
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.
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).
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.
DRG REF EI
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article of drug appears to be adulterated under Section 501(j) because it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.
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 |
|---|---|---|---|
| 9/27/2021 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 3845DRG REF EI | Division of West Coast Imports (DWCI) |
| 9/23/2021 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 7/1/2021 | 65LBY11TITANIUM DIOXIDE (PROTECTANT) | Division of West Coast Imports (DWCI) | |
| 5/24/2021 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of West Coast Imports (DWCI) | |
| 5/24/2021 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of West Coast Imports (DWCI) | |
| 10/16/2012 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | San Francisco District Office (SAN-DO) | |
| 10/16/2012 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | San Francisco District Office (SAN-DO) | |
| 10/16/2012 | 53GC05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | San Francisco District Office (SAN-DO) | |
| 10/16/2012 | 53GH02FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
| 10/16/2012 | 53GH01BLUSHERS (ALL TYPES) (MAKEUP PREPARATIONS, NOT FOR EYES) | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
| 10/16/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 10/16/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 10/16/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 10/16/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 10/16/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 10/16/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Eyesome Co., Ltd.'s FDA import refusal history?
Eyesome Co., Ltd. (FEI: 3010235400) has 16 FDA import refusal record(s) in our database, spanning from 10/16/2012 to 9/27/2021.
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. Eyesome Co., Ltd.'s FEI number is 3010235400.
What types of violations has Eyesome Co., Ltd. received?
Eyesome Co., Ltd. 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 Eyesome Co., Ltd. come from?
All FDA import refusal data for Eyesome 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.