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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 EJ2-0107257-9/38/2


Manufacturer FEI3002574623
Manufacturer NameUnilever India Export Ltd.  
Manufacturer Address line 1Plot 253-257, Sector-IV,  
Manufacturer Address line 2Kandla Special Economic Zone  
Manufacturer's CityGandhidham  
Manufacturer Province/StateGujaarat  
Manufacturer Country/AreaIndia  
Product Code53LC99  
Importer's Product DescriptionFAIR AND LOVELY REGULAR  
Refusal Date26-Oct-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx EJ2-0107257-9/38/2
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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