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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 AEK-0332163-1/1/1

Manufacturer FEI3009533122
Manufacturer NameMandiri Bersama  
Manufacturer Address line 1Cv Adi Sucipto No 26  
Manufacturer Address line 2  
Manufacturer's CityPoontianak  
Manufacturer Province/State  
Manufacturer Country/AreaIndonesia  
Product Code53PD99  
Importer's Product DescriptionMYTRAGYNA SPECIOSA  
Refusal Date21-Jun-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx AEK-0332163-1/1/1
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.  
UNSFDIETSP   402(f)(1)(B), 801(a)(3) Adulteration   The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.