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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 112-7774120-8/1/2

Manufacturer FEI3008855266
Manufacturer NameShree Marwal Sevashram  
Manufacturer Address line 1Plot No. 4-5, A.B Industrial Est  
Manufacturer Address line 2  
Manufacturer's CityIndore  
Manufacturer Province/State  
Manufacturer Country/AreaIndia  
Product Code53LD99  
Importer's Product Description798392382267 APPLICANT MASSAGE GEL  
Refusal Date06-Jul-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-7774120-8/1/2
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.