Natuzen Co., Ltd.
⚠️ Moderate Risk
FEI: 3006731547 • Namdong District, Incheon • SOUTH KOREA
FEI Number
3006731547
Location
Namdong District, Incheon
Country
SOUTH KOREAAddress
(nonhyeonng) 47b-8l, Namdong Ind. Complex, 289, Namdongdong-ro, Namdong District, Incheon, 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.
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).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/30/2024 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 5/18/2009 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | Baltimore District Office (BLT-DO) | |
| 4/30/2008 | 53LY01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Seattle District Office (SEA-DO) |
| 4/21/2008 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Natuzen Co., Ltd.'s FDA import refusal history?
Natuzen Co., Ltd. (FEI: 3006731547) has 4 FDA import refusal record(s) in our database, spanning from 4/21/2008 to 5/30/2024.
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. Natuzen Co., Ltd.'s FEI number is 3006731547.
What types of violations has Natuzen Co., Ltd. received?
Natuzen 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 Natuzen Co., Ltd. come from?
All FDA import refusal data for Natuzen 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.