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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 H77-0134654-3/4/3

Manufacturer FEI3008985479
Manufacturer NameHemani International  
Manufacturer Address line 1Plot No. 11, Sector A-IV Karachi 75150  
Manufacturer Address line 2  
Manufacturer's CityKarachi  
Manufacturer Province/StateSindh  
Manufacturer Country/AreaPakistan  
Product Code53JC99  
Importer's Product DescriptionASSORTED CREAM  
Refusal Date15-Jan-2013  
FDA DistrictSWI-DO  
Entry/doc/line/sfx H77-0134654-3/4/3
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
LACKS FIRM   502(b)(1), 801(a)(3); MISBRANDING   The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.  
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.