Eminence Organic Skin Care Inc.
⚠️ Moderate Risk
FEI: 3003615307 • Vancouver, British Columbia • CANADA
FEI Number
3003615307
Location
Vancouver, British Columbia
Country
CANADAAddress
1715 Cook Street, Unit 201, , Vancouver, British Columbia, Canada
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).
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).
COSM MISB
The cosmetic's labeling appears to be false or misleading within the meaning of Section 201(n).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/25/2019 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/25/2019 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/25/2019 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/26/2018 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/27/2013 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Seattle District Office (SEA-DO) | |
| 3/27/2013 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Seattle District Office (SEA-DO) | |
| 2/22/2013 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 1/29/2013 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 4/23/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 4/20/2012 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 4/20/2012 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 4/20/2012 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 12/29/2011 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 12/16/2011 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 12/16/2011 | 62GCY99ANTI-INFLAMMATORY N.E.C. | Seattle District Office (SEA-DO) | |
| 9/10/2009 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 8/19/2008 | 53LG09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Seattle District Office (SEA-DO) |
| 9/22/2006 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 8/30/2006 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Eminence Organic Skin Care Inc.'s FDA import refusal history?
Eminence Organic Skin Care Inc. (FEI: 3003615307) has 19 FDA import refusal record(s) in our database, spanning from 8/30/2006 to 3/25/2019.
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. Eminence Organic Skin Care Inc.'s FEI number is 3003615307.
What types of violations has Eminence Organic Skin Care Inc. received?
Eminence Organic Skin Care Inc. 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 Eminence Organic Skin Care Inc. come from?
All FDA import refusal data for Eminence Organic Skin Care Inc. 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.