Nikki Beach Beauty
⚠️ Moderate Risk
FEI: 3009032889 • Zollikerberg, Zh • SWITZERLAND
FEI Number
3009032889
Location
Zollikerberg, Zh
Country
SWITZERLANDAddress
Buhlstrasse 1, , Zollikerberg, Zh, Switzerland
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/26/2012 | 53GC03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | Florida District Office (FLA-DO) | |
| 4/26/2012 | 53GC03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | Florida District Office (FLA-DO) | |
| 4/26/2012 | 53GC03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | Florida District Office (FLA-DO) | |
| 4/26/2012 | 53GC03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | Florida District Office (FLA-DO) | |
| 4/26/2012 | 53GC03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Nikki Beach Beauty's FDA import refusal history?
Nikki Beach Beauty (FEI: 3009032889) has 5 FDA import refusal record(s) in our database, spanning from 4/26/2012 to 4/26/2012.
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. Nikki Beach Beauty's FEI number is 3009032889.
What types of violations has Nikki Beach Beauty received?
Nikki Beach Beauty 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 Nikki Beach Beauty come from?
All FDA import refusal data for Nikki Beach Beauty 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.