ROYAL DISTRIBUTION COTE D'IVOIRE
⚠️ Moderate Risk
FEI: 3007808211 • Abidjan • IVORY COAST
FEI Number
3007808211
Location
Abidjan
Country
IVORY COASTAddress
Bp 1282, , 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).
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.
COSM MISB2
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears that its labeling is false or misleading in any particular.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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.
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.
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 |
|---|---|---|---|
| 8/19/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/26/2019 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | Division of Northeast Imports (DNEI) | |
| 2/2/2011 | 65GCY99PIGMENTATION AGENT N.E.C. | New York District Office (NYK-DO) | |
| 2/2/2011 | 65GCY99PIGMENTATION AGENT N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is ROYAL DISTRIBUTION COTE D'IVOIRE's FDA import refusal history?
ROYAL DISTRIBUTION COTE D'IVOIRE (FEI: 3007808211) has 4 FDA import refusal record(s) in our database, spanning from 2/2/2011 to 8/19/2025.
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. ROYAL DISTRIBUTION COTE D'IVOIRE's FEI number is 3007808211.
What types of violations has ROYAL DISTRIBUTION COTE D'IVOIRE received?
ROYAL DISTRIBUTION COTE D'IVOIRE 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 ROYAL DISTRIBUTION COTE D'IVOIRE come from?
All FDA import refusal data for ROYAL DISTRIBUTION COTE D'IVOIRE 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.