Picos-Ci
⚠️ High Risk
FEI: 3005845511 • Abidjan • IVORY COAST
FEI Number
3005845511
Location
Abidjan
Country
IVORY COASTAddress
Cfa Zone Industrielle De Yopougon03 Bp, , Abidjan, , Ivory Coast
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
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).
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
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.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/2/2024 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of Northeast Imports (DNEI) | |
| 5/2/2024 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Division of Northeast Imports (DNEI) | |
| 5/2/2024 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of Northeast Imports (DNEI) | |
| 5/2/2024 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of Northeast Imports (DNEI) | |
| 5/2/2024 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Division of Northeast Imports (DNEI) | |
| 5/2/2024 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of Northeast Imports (DNEI) | |
| 9/7/2017 | 63VBY99DEPIGMENTOR N.E.C. | Division of Northeast Imports (DNEI) | |
| 10/30/2014 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 10/30/2014 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 8/28/2013 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Division of Northeast Imports (DNEI) | |
| 10/19/2010 | 63VDL02HYDROQUINONE (DEPIGMENTOR) | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/26/2010 | 63VBL02HYDROQUINONE (DEPIGMENTOR) | Division of Northeast Imports (DNEI) | |
| 5/26/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 5/26/2010 | 64XBL06SALICYLIC ACID (KERATOLYTIC) | Division of Northeast Imports (DNEI) | |
| 5/26/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 4/29/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 472NO ENGLISH | Division of Northeast Imports (DNEI) |
| 4/28/2010 | 66VBU99MISCELLANEOUS PATENT MEDICINES, ETC. | 472NO ENGLISH | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Picos-Ci's FDA import refusal history?
Picos-Ci (FEI: 3005845511) has 17 FDA import refusal record(s) in our database, spanning from 4/28/2010 to 5/2/2024.
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. Picos-Ci's FEI number is 3005845511.
What types of violations has Picos-Ci received?
Picos-Ci has been cited for 8 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 Picos-Ci come from?
All FDA import refusal data for Picos-Ci 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.