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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 KM6-0057093-1/15/1

Manufacturer FEI3008473286
Manufacturer NameKeval Exports Pvt.Ltd  
Manufacturer Address line 1303 A.P.M.C.Market-I,Phase-Ii,Vashinavi  
Manufacturer Address line 2  
Manufacturer's CityMumbai  
Manufacturer Province/State  
Manufacturer Country/AreaIndia  
Product Code53IG01  
Importer's Product DescriptionTOOTHPASTE  
Refusal Date03-Aug-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx KM6-0057093-1/15/1
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).