Import Refusal Report

Refusal Details as Recorded in OASIS by FDA

Manufacturer FEI

3009032889

Manufacturer Name

Nikki Beach Beauty

Manufacturer Address line 1

Buhlstrasse 1

Manufacturer Address line 2

Manufacturer's City

Zollikerberg

Manufacturer Province/State

Manufacturer Country/Area

Switzerland

Product Code

53GC03

Importer's Product Description

SUN CREAM SPF 6

Refusal Date

26-Apr-2012

FDA District

FLA-DO

Entry/doc/line/sfx

554-3425386-4/1/1

FDA Sample Analysis

FDA Record of Private Lab Sample Analysis

Charge(s)

Violation Code	Section	Charge Statement
FRNMFGREG	502(o), 801(a)(3); MISBRANDING	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&CA. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act. [Misbranding, Section 502(o), 801(a)(3)].?
NOT LISTED	502(o), 801(a)(3); MISBRANDING	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).
UNAPPROVED	505(a), 801(a)(3); UNAPPROVED NEW DRUG	The article appears to be a new drug without an approved new drug application.