Import Refusal Report

Refusal Details as Recorded in OASIS by FDA

Manufacturer FEI

3008690064

Manufacturer Name

Nesura Cosmetics

Manufacturer Address line 1

285-1 Jwagyo-Ri , Godeok-Myeon

Manufacturer Address line 2

Manufacturer's City

Pyeong Taek Si

Manufacturer Province/State

Manufacturer Country/Area

Korea, Republic Of (South)

Product Code

53LC03

Importer's Product Description

BLOCK & BLOCK ORIGINAL SUN CREAM

Refusal Date

10-Oct-2011

FDA District

LOS-DO

Entry/doc/line/sfx

CAY-1028054-0/23/1

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.
DRUG NAME	502(e)(1); 801(a)(3); Misbranding	The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
LACKS N/C	502(b)(2), 801(a)(3); MISBRANDING	The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
NO ENGLISH	502(c); 801(a)(3);Misbranding	Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
UNAPPROVED	505(a), 801(a)(3); UNAPPROVED NEW DRUG	The article appears to be a new drug without an approved new drug application.