Enprani Co., Ltd.
⚠️ High Risk
FEI: 3010822322 • Jung • SOUTH KOREA
FEI Number
3010822322
Location
Jung
Country
SOUTH KOREAAddress
88 Chukhangdaero296beon-Gil, , Jung, , 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
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).
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).
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.
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.
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.
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
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.
COSM MISB2
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears that its labeling is false or misleading in any particular.
COSM MISB
The cosmetic's labeling appears to be false or misleading within the meaning of Section 201(n).
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.
DRUG COLOR
The article appears to be a color additive the intended use of which is for the purpose of coloring only, and its packaging and labeling do not conform to regulations issued under section 721.
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 |
|---|---|---|---|
| 9/19/2025 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 6/9/2025 | 53LY03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 6/9/2025 | 53LY03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/9/2025 | 66XBJ04HOMEOPATHIC DERMATOLOGICAL | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 5/9/2025 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 5/9/2025 | 66XBJ04HOMEOPATHIC DERMATOLOGICAL | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 5/9/2025 | 66XBO04HOMEOPATHIC DERMATOLOGICAL | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 1/18/2024 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 1/18/2024 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 10/4/2023 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 10/4/2023 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 10/4/2023 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 2/1/2023 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 12/26/2019 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Northeast Imports (DNEI) | |
| 12/26/2019 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Northeast Imports (DNEI) | |
| 12/26/2019 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 6/1/2016 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 2280DIRSEXMPT | New York District Office (NYK-DO) |
| 6/1/2016 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | New York District Office (NYK-DO) |
| 1/12/2015 | 53GY99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. | Atlanta District Office (ATL-DO) | |
| 1/12/2015 | 53LY06MOISTURIZING (SKIN CARE PREPARATIONS) | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Enprani Co., Ltd.'s FDA import refusal history?
Enprani Co., Ltd. (FEI: 3010822322) has 20 FDA import refusal record(s) in our database, spanning from 1/12/2015 to 9/19/2025.
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. Enprani Co., Ltd.'s FEI number is 3010822322.
What types of violations has Enprani Co., Ltd. received?
Enprani Co., Ltd. has been cited for 16 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 Enprani Co., Ltd. come from?
All FDA import refusal data for Enprani 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.