Ets Sanon Ami
⚠️ Moderate Risk
FEI: 3008282047 • Abidjan • IVORY COAST
FEI Number
3008282047
Location
Abidjan
Country
IVORY COASTAddress
03 B.P. 216 Abidjan, , Abidjan, , Ivory Coast
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).
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.
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.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
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.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/13/2018 | 63VDY99DEPIGMENTOR N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/18/2018 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | Division of Northeast Imports (DNEI) |
| 5/18/2018 | 60QBQ07LIDOCAINE | Division of Northeast Imports (DNEI) | |
| 4/20/2018 | 63VDY02HYDROQUINONE (DEPIGMENTOR) | 223FALSE | Division of Northeast Imports (DNEI) |
| 4/20/2018 | 60QAY07LIDOCAINE | Division of Northeast Imports (DNEI) | |
| 4/20/2018 | 60QAY07LIDOCAINE | Division of Northeast Imports (DNEI) | |
| 4/20/2018 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 4/20/2018 | 54FYY13GOTU KOLA (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 3/23/2011 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 3/23/2011 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 3/23/2011 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 3/23/2011 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 3/23/2011 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/8/2010 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 9/8/2010 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 9/8/2010 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 9/8/2010 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 9/8/2010 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 9/8/2010 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 9/8/2010 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 9/8/2010 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Ets Sanon Ami's FDA import refusal history?
Ets Sanon Ami (FEI: 3008282047) has 21 FDA import refusal record(s) in our database, spanning from 9/8/2010 to 8/13/2018.
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. Ets Sanon Ami's FEI number is 3008282047.
What types of violations has Ets Sanon Ami received?
Ets Sanon Ami has been cited for 11 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 Ets Sanon Ami come from?
All FDA import refusal data for Ets Sanon Ami 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.