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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 185-0056103-2/19/1

Manufacturer FEI3002108159
Manufacturer NameAayu Impex  
Manufacturer Address line 1Shop No.1, Pavapuri Apts 9th Khetwadi  
Manufacturer Address line 2  
Manufacturer's CityBombay  
Manufacturer Province/State  
Manufacturer Country/AreaIndia  
Product Code53EH06  
Importer's Product DescriptionAMLA POWDER  
Refusal Date07-Oct-2011  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 185-0056103-2/19/1
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.