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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 XXX-0173200-8/1/1/F


Manufacturer FEI3008110314
Manufacturer NameComputerized Body Reading  
Manufacturer Address line 1707 27 St N  
Manufacturer Address line 2  
Manufacturer's CityLethbridge  
Manufacturer Province/StateALBERTA  
Manufacturer Country/AreaCanada  
Product Code66VBL99  
FDA Product DescriptionMISCELLANEOUS PATENT MEDICINES, ETC.  
Refusal Date18-May-2010  
FDA DistrictMIN-DO  
Entry/doc/line/sfx XXX-0173200-8/1/1/F
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.  
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