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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 988-0243042-5/2/1


Manufacturer FEI3008117438
Manufacturer NameEver Bamboo Inc  
Manufacturer Address line 1919 Centre St Nw  
Manufacturer Address line 2#261  
Manufacturer's CityCalgary  
Manufacturer Province/StateAlberta  
Manufacturer Country/AreaCanada  
Product Code53JK01  
Importer's Product DescriptionBAMBOO CHARCOAL FACE + BODY SOAP BAR  
Refusal Date02-Nov-2012  
FDA DistrictSEA-DO  
Entry/doc/line/sfx 988-0243042-5/2/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.  
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