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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 KM6-0057195-4/12/1

Manufacturer FEI3006391121
Manufacturer NameDabur India Ltd Baddi Oral Care Unit  
Manufacturer Address line 1601, MALKUMAJRA, NALAGARH ROAD  
Manufacturer Address line 2BADDI TEHSIL ALAGARH, DIST. SOLAN  
Manufacturer's CitySOLAN  
Manufacturer Province/StateIN-HP  
Manufacturer Country/AreaIndia  
Product Code53IG01  
Importer's Product DescriptionTOOTH PASTE  
Refusal Date20-Jun-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx KM6-0057195-4/12/1
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.