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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 MQ9-0135608-8/6/2/B


Manufacturer FEI3008468440
Manufacturer NameDabur India Limited  
Manufacturer Address line 1601, Malku Majra  
Manufacturer Address line 2Nalagarg Road  
Manufacturer's CityBaddi District  
Manufacturer Province/StateSolan  
Manufacturer Country/AreaIndia  
Product Code53IG01  
Importer's Product DescriptionTOOTHPASTE BABUL  
Refusal Date31-Jan-2013  
FDA DistrictLOS-DO  
Entry/doc/line/sfx MQ9-0135608-8/6/2/B
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).  
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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