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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 BYA-0125739-3/18/1

Manufacturer FEI3004356927
Manufacturer NameHindustan Lever Ltd.  
Manufacturer Address line 1Dag No.21 Of 122 F.s.grant, Mouza-tingra  
Manufacturer Address line 2Doomdooma Industrial Estate, Off Nh-37  
Manufacturer's CityMumbai  
Manufacturer Province/StateTinsukia District  
Manufacturer Country/AreaIndia  
Product Code53LC03  
Importer's Product DescriptionFAIR & LOVELY WINTER FAIRNESS CREAM  
Refusal Date04-Apr-2013  
FDA DistrictSWI-DO  
Entry/doc/line/sfx BYA-0125739-3/18/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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.