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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 004-5992522-8/5/1

Manufacturer FEI3007689639
Manufacturer NameYogi Botanicals  
Manufacturer Address line 1C-24 East Nizamuddin  
Manufacturer Address line 2New delhi  
Manufacturer's CityNew Delhi  
Manufacturer Province/StateIN-DL  
Manufacturer Country/AreaIndia  
Product Code53LC03  
Importer's Product DescriptionPEARL WHITE CREAM MASK  
Refusal Date14-Dec-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx 004-5992522-8/5/1
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.