H Cosmetiques CI
⚠️ High Risk
FEI: 3010166042 • Abidjan • IVORY COAST
FEI Number
3010166042
Location
Abidjan
Country
IVORY COASTAddress
75 ADJAME MAIRIE, RUE BANDAMA-Lot, , 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
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).
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.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks 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.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/28/2024 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 8/28/2024 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/7/2021 | 64LCY67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | Division of Northeast Imports (DNEI) | |
| 5/7/2021 | 64LDY67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | Division of Northeast Imports (DNEI) | |
| 8/13/2018 | 63VCY02HYDROQUINONE (DEPIGMENTOR) | Division of Northeast Imports (DNEI) | |
| 8/3/2016 | 66YAU99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 8/3/2016 | 66YAU99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 7/15/2016 | 64LCJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | Division of Northeast Imports (DNEI) | |
| 7/15/2016 | 64LCJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | Division of Northeast Imports (DNEI) | |
| 7/15/2016 | 64LCJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | Division of Northeast Imports (DNEI) | |
| 7/15/2016 | 64LCJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | Division of Northeast Imports (DNEI) | |
| 1/18/2013 | 63VBJ02HYDROQUINONE (DEPIGMENTOR) | New England District Office (NWE-DO) | |
| 1/18/2013 | 63VBJ02HYDROQUINONE (DEPIGMENTOR) | New England District Office (NWE-DO) |
Frequently Asked Questions
What is H Cosmetiques CI's FDA import refusal history?
H Cosmetiques CI (FEI: 3010166042) has 13 FDA import refusal record(s) in our database, spanning from 1/18/2013 to 8/28/2024.
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. H Cosmetiques CI's FEI number is 3010166042.
What types of violations has H Cosmetiques CI received?
H Cosmetiques CI has been cited for 10 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 H Cosmetiques CI come from?
All FDA import refusal data for H Cosmetiques 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.