Ezekiel Cosmetics Co.
⚠️ Moderate Risk
FEI: 3011400575 • Incheon • SOUTH KOREA
FEI Number
3011400575
Location
Incheon
Country
SOUTH KOREAAddress
28-17 Namdongseo-ro 113beon-gil, Namdong-gu, , 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
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).
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.
708NOREG
It has been determined the drug was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/23/2021 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 6/23/2017 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Northeast Imports (DNEI) | |
| 6/23/2017 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Northeast Imports (DNEI) | |
| 6/23/2017 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Northeast Imports (DNEI) | |
| 12/12/2016 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 1/8/2016 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 3280FRNMFGREG | Chicago District Office (CHI-DO) |
| 1/8/2016 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 3280FRNMFGREG | Chicago District Office (CHI-DO) |
| 1/8/2016 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 3280FRNMFGREG | Chicago District Office (CHI-DO) |
| 1/8/2016 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 3280FRNMFGREG | Chicago District Office (CHI-DO) |
| 4/15/2015 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/15/2015 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/8/2015 | 63VBY99DEPIGMENTOR N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Ezekiel Cosmetics Co.'s FDA import refusal history?
Ezekiel Cosmetics Co. (FEI: 3011400575) has 12 FDA import refusal record(s) in our database, spanning from 4/8/2015 to 6/23/2021.
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. Ezekiel Cosmetics Co.'s FEI number is 3011400575.
What types of violations has Ezekiel Cosmetics Co. received?
Ezekiel Cosmetics Co. has been cited for 7 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 Ezekiel Cosmetics Co. come from?
All FDA import refusal data for Ezekiel Cosmetics Co. 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.