Nouvelle Cosmetologie Kaera
⚠️ High Risk
FEI: 3011321151 • Abidjan • IVORY COAST
FEI Number
3011321151
Location
Abidjan
Country
IVORY COASTAddress
Zone Industrielle De Yopougon, , 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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
FALSEDRUG
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug which is misbranded within the meaning of section 502(a)(1) in that its labeling is false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/10/2024 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of Northeast Imports (DNEI) | |
| 4/10/2024 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of Northeast Imports (DNEI) | |
| 4/10/2024 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of Northeast Imports (DNEI) | |
| 3/21/2024 | 63VAY99DEPIGMENTOR N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Nouvelle Cosmetologie Kaera's FDA import refusal history?
Nouvelle Cosmetologie Kaera (FEI: 3011321151) has 4 FDA import refusal record(s) in our database, spanning from 3/21/2024 to 4/10/2024.
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. Nouvelle Cosmetologie Kaera's FEI number is 3011321151.
What types of violations has Nouvelle Cosmetologie Kaera received?
Nouvelle Cosmetologie Kaera has been cited for 3 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 Cosmetologie Kaera come from?
All FDA import refusal data for Nouvelle Cosmetologie Kaera 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.