Siparco
⚠️ Moderate Risk
FEI: 3003786275 • Abidjan • IVORY COAST
FEI Number
3003786275
Location
Abidjan
Country
IVORY COASTAddress
C101 B P906, , 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
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/11/2014 | 55QY74COCOA BUTTER (PHARMACEUTIC NECESSITY - SUPPOSITORY BASE) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 6/11/2014 | 55QY74COCOA BUTTER (PHARMACEUTIC NECESSITY - SUPPOSITORY BASE) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 1/30/2014 | 55QY74COCOA BUTTER (PHARMACEUTIC NECESSITY - SUPPOSITORY BASE) | 118NOT LISTED | New York District Office (NYK-DO) |
| 1/30/2014 | 65LAY99PROTECTANT N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 1/30/2014 | 55QY74COCOA BUTTER (PHARMACEUTIC NECESSITY - SUPPOSITORY BASE) | 118NOT LISTED | New York District Office (NYK-DO) |
| 4/6/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 473LABELING | New York District Office (NYK-DO) |
| 4/6/2011 | 53BC99OTHER BATH PREPARATIONS, N.E.C. | 473LABELING | New York District Office (NYK-DO) |
| 4/6/2011 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 4/6/2011 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 4/6/2011 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 4/6/2011 | 63VBJ02HYDROQUINONE (DEPIGMENTOR) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 4/6/2011 | 63VBJ02HYDROQUINONE (DEPIGMENTOR) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 4/6/2011 | 63VBY02HYDROQUINONE (DEPIGMENTOR) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 4/6/2011 | 63VBY02HYDROQUINONE (DEPIGMENTOR) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 3/31/2011 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 3/31/2011 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Siparco's FDA import refusal history?
Siparco (FEI: 3003786275) has 16 FDA import refusal record(s) in our database, spanning from 3/31/2011 to 6/11/2014.
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. Siparco's FEI number is 3003786275.
What types of violations has Siparco received?
Siparco has been cited for 4 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 Siparco come from?
All FDA import refusal data for Siparco 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.