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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 MQ9-0119326-7/4/1

Manufacturer FEI3004672062
Manufacturer NameM.M. Enterprise  
Manufacturer Address line 1J B House Borsad (388540)  
Manufacturer Address line 2  
Manufacturer's CityBorsad  
Manufacturer Province/StateGujarat  
Manufacturer Country/AreaIndia  
Product Code66VDY99  
Importer's Product DescriptionMESWAK TOOTH PASTE  
Refusal Date22-Sep-2010  
FDA DistrictLOS-DO  
Entry/doc/line/sfx MQ9-0119326-7/4/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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).