Nowcos Co., Ltd
⚠️ High Risk
FEI: 3009968674 • Sejong, Sejong • SOUTH KOREA
FEI Number
3009968674
Location
Sejong, Sejong
Country
SOUTH KOREAAddress
220 Sandan-Gil, Jeonui-Myeon, Sejong, Sejong, South Korea
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
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).
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
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.
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/15/2025 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 10/15/2025 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 9/5/2025 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/21/2025 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 4/15/2025 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 7/24/2024 | 53BD01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 12/14/2023 | 53FY01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | Division of West Coast Imports (DWCI) |
| 12/14/2023 | 53FY01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | Division of West Coast Imports (DWCI) |
| 11/21/2023 | 53FY01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | Division of West Coast Imports (DWCI) |
| 11/21/2023 | 53FY01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 198COLOR LBLG | Division of West Coast Imports (DWCI) |
| 6/27/2022 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Division of West Coast Imports (DWCI) |
| 5/21/2021 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of West Coast Imports (DWCI) | |
| 7/2/2019 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 1/22/2019 | 64XBL06SALICYLIC ACID (KERATOLYTIC) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 1/15/2019 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 1/15/2019 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 6/9/2015 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/9/2015 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/9/2015 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/9/2015 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/9/2015 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/9/2015 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/9/2015 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/9/2015 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 1/12/2015 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Atlanta District Office (ATL-DO) | |
| 4/22/2010 | 63XBL99DIAGOSTIC AID (DRUGS) N.E.C. | Baltimore District Office (BLT-DO) | |
| 4/22/2010 | 66VBO99MISCELLANEOUS PATENT MEDICINES, ETC. | Baltimore District Office (BLT-DO) | |
| 3/31/2009 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/3/2007 | 66PCY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Nowcos Co., Ltd's FDA import refusal history?
Nowcos Co., Ltd (FEI: 3009968674) has 29 FDA import refusal record(s) in our database, spanning from 10/3/2007 to 10/15/2025.
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. Nowcos Co., Ltd's FEI number is 3009968674.
What types of violations has Nowcos Co., Ltd received?
Nowcos 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 Nowcos Co., Ltd come from?
All FDA import refusal data for Nowcos 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.