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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-0774412-7/1/1

Manufacturer FEI2000028016
Manufacturer NameShenzhen Shenbao Huacheng Tech.Co.,Ltd.  
Manufacturer Address line 1Jinyuanlu  
Manufacturer Address line 2Heao, Henggang Longgang  
Manufacturer's CityShenzh┬┐nsh┬┐  
Manufacturer Province/StateYandongsheng  
Manufacturer Country/AreaChina  
Product Code53YY99  
Importer's Product DescriptionFOOTPATCH  
Refusal Date15-Jan-2013  
FDA DistrictLOS-DO  
Entry/doc/line/sfx AEK-0774412-7/1/1
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.