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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 231-7141753-0/1/4

Manufacturer FEI3010165928
Manufacturer NameVikas Laboratories Pvt. Ltd.  
Manufacturer Address line 1Plot No R / 891, TTC Industrial  
Manufacturer Address line 2  
Manufacturer's CityNavi Mumbai  
Manufacturer Province/StateMaharashtra  
Manufacturer Country/AreaIndia  
Product Code53JK01  
Importer's Product DescriptionFRESH SCENT SOAP# 1 (CANDY WRAP)  
Refusal Date02-Jan-2013  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 231-7141753-0/1/4
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).