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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 H77-0134654-3/4/1

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 Code53EC99  
Importer's Product DescriptionASSORTED CREAM  
Refusal Date26-Dec-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx H77-0134654-3/4/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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).