Import Refusal Report

Refusal Details as Recorded in OASIS by FDA

Manufacturer FEI

3007056860

Manufacturer Name

Kolmar Korea

Manufacturer Address line 1

1603-55, Seocho-Dong, Seocho-Gu

Manufacturer Address line 2

Manufacturer's City

SEOUL

Manufacturer Province/State

KR-11

Manufacturer Country/Area

Korea, Republic Of (South)

Product Code

53LD06

Importer's Product Description

THE CELLIN EOP NANOSKIN CREAM PACK, 3CT, 384PC

Refusal Date

01-Nov-2011

FDA District

LOS-DO

Entry/doc/line/sfx

BMI-1016449-0/1/1

FDA Sample Analysis

FDA Record of Private Lab Sample Analysis

Charge(s)

Violation Code	Section	Charge Statement
COSM COLOR	601(e), 801(a)(3); ADULTERATION	The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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).
POISONOUS	601(a), 801(a)(3); ADULTERATION	The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
UNAPPROVED	505(a), 801(a)(3); UNAPPROVED NEW DRUG	The article appears to be a new drug without an approved new drug application.