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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 MQ9-0135608-8/6/4

Manufacturer FEI3008468427
Manufacturer NameWf Limited  
Manufacturer Address line 1No. 28 S. Roy Road  
Manufacturer Address line 2  
Manufacturer's CityKolkata  
Manufacturer Province/State  
Manufacturer Country/AreaIndia  
Product Code53IG01  
Importer's Product DescriptionTOOTHPASTE ACTIVE  
Refusal Date31-Jan-2013  
FDA DistrictLOS-DO  
Entry/doc/line/sfx MQ9-0135608-8/6/4
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
DIRSEXMPT   502(f)(1), 801(a)(3); MISBRANDING   The article appears to lack adequate directions for use, and the article does not appear to be exempt from such requirements.  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.