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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Details as Recorded in OASIS by FDA

for Refusal 429-0777577-1/2/1


Manufacturer FEI3008418130
Manufacturer NameMustafa Enterprises  
Manufacturer Address line 1MR 5/88, Thanai Lane, Jodia Bazar  
Manufacturer Address line 2  
Manufacturer's CityKarachi  
Manufacturer Province/StatePK-SD  
Manufacturer Country/AreaPakistan  
Product Code53LD06  
FDA Product DescriptionMOISTURIZING (SKIN CARE PREPARATIONS)  
Refusal Date23-Jul-2012  
FDA DistrictSEA-DO  
Entry/doc/line/sfx 429-0777577-1/2/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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.  
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