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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 DO7-8396989-5/1/1

Manufacturer FEI3009613088
Manufacturer NameBorneo Botanicals  
Manufacturer Address line 1Depok Jaya Agungjl Melon Raya A-4 No 12  
Manufacturer Address line 2  
Manufacturer's CitySepong  
Manufacturer Province/State  
Manufacturer Country/AreaIndonesia  
Product Code53DH99  
Importer's Product DescriptionNAUCLEA SPECIOSA POWDER  
Refusal Date25-Oct-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx DO7-8396989-5/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
DIET INGRE   402(a)(3), 801(a)(3); Adulteration   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be for use as an ingredient in a dietary supplement and appears to be or may be otherwise unfit for food.