Nouvelle Parfumerie Gandour
⚠️ Moderate Risk
FEI: 3011185297 • Abidjan • IVORY COAST
FEI Number
3011185297
Location
Abidjan
Country
IVORY COASTAddress
01 Bp 8093, , 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).
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.
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).
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/7/2015 | 63VBY02HYDROQUINONE (DEPIGMENTOR) | Division of Northeast Imports (DNEI) | |
| 4/7/2015 | 63VBU02HYDROQUINONE (DEPIGMENTOR) | Division of Northeast Imports (DNEI) | |
| 4/7/2015 | 63VBY02HYDROQUINONE (DEPIGMENTOR) | Division of Northeast Imports (DNEI) | |
| 4/7/2015 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 4/7/2015 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 4/7/2015 | 63VAJ02HYDROQUINONE (DEPIGMENTOR) | Division of Northeast Imports (DNEI) | |
| 4/7/2015 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 4/7/2015 | 63VAJ02HYDROQUINONE (DEPIGMENTOR) | Division of Northeast Imports (DNEI) | |
| 4/7/2015 | 63VBY02HYDROQUINONE (DEPIGMENTOR) | Division of Northeast Imports (DNEI) | |
| 4/7/2015 | 63VAJ02HYDROQUINONE (DEPIGMENTOR) | Division of Northeast Imports (DNEI) | |
| 4/7/2015 | 63VBY02HYDROQUINONE (DEPIGMENTOR) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Nouvelle Parfumerie Gandour's FDA import refusal history?
Nouvelle Parfumerie Gandour (FEI: 3011185297) has 11 FDA import refusal record(s) in our database, spanning from 4/7/2015 to 4/7/2015.
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. Nouvelle Parfumerie Gandour's FEI number is 3011185297.
What types of violations has Nouvelle Parfumerie Gandour received?
Nouvelle Parfumerie Gandour has been cited for 6 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 Nouvelle Parfumerie Gandour come from?
All FDA import refusal data for Nouvelle Parfumerie Gandour 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.