Import Refusal Report

Refusal Details as Recorded in OASIS by FDA

Manufacturer FEI

3008418130

Manufacturer Name

Mustafa Enterprises

Manufacturer Address line 1

MR 5/88, Thanai Lane, Jodia Bazar

Manufacturer Address line 2

Manufacturer's City

Karachi

Manufacturer Province/State

PK-SD

Manufacturer Country/Area

Pakistan

Product Code

53LD06

Importer's Product Description

BODY OIL MOISTURIZER

Refusal Date

23-Jul-2012

FDA District

SEA-DO

Entry/doc/line/sfx

429-0777577-1/2/1

FDA Sample Analysis

FDA Record of Private Lab Sample Analysis

Charge(s)

Violation Code	Section	Charge Statement
DIETARYLBL	403(s)(2)(B), 801(a)(3), misbranded	The label/labeling of the dietary supplement fails to identify the product by using the term "dietary supplement".
LABELING	Section 4(a); 801(a)(3) Misbranding	The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
NUTRIT LBL	403(q); 801(a)(3); Misbranding	The article appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
UNAPPROVED	505(a), 801(a)(3); UNAPPROVED NEW DRUG	The article appears to be a new drug without an approved new drug application.