Import Refusal Report

Refusal Details as Recorded in OASIS by FDA

Manufacturer FEI

3003265846

Manufacturer Name

Inel Cosmetics Co.

Manufacturer Address line 1

Pang Idong 108

Manufacturer Address line 2

Songpa-gu

Manufacturer's City

Seoul

Manufacturer Province/State

Seoul

Manufacturer Country/Area

Korea, Republic Of (South)

Product Code

53LC99

Importer's Product Description

PORE APPLE CREAM

Refusal Date

10-Oct-2011

FDA District

LOS-DO

Entry/doc/line/sfx

E8L-1013229-3/6/1

FDA Sample Analysis

FDA Record of Private Lab Sample Analysis

Charge(s)

Violation Code	Section	Charge Statement
DIRECTIONS	502(f)(1), 801(a)(3); MISBRANDING	The article appears to lack adequate directions for use.
FALSE	502(a), 801(a)(3); MISBRANDING	The labeling for this article appears to be false or misleading
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).