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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 KM6-0053484-6/13/1


Manufacturer FEI3004509195
Manufacturer NameUnilever Pakistan Limited  
Manufacturer Address line 1Avari Plaza  
Manufacturer Address line 2Fatima Jinnah Road  
Manufacturer's CityKarachi  
Manufacturer Province/State  
Manufacturer Country/AreaPakistan  
Product Code53LC03  
Importer's Product DescriptionFAIRNESS CREAM  
Refusal Date17-Oct-2011  
FDA DistrictNYK-DO  
Entry/doc/line/sfx KM6-0053484-6/13/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
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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