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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-9640386-6/1/1

Manufacturer FEI3007895157
Manufacturer NameTrans Power  
Manufacturer Address line 1Kin Yip Manufactor  
Manufacturer Address line 2  
Manufacturer's CityShenzhen  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code89MZX  
Importer's Product DescriptionSMOKELESS TOBACCO N.E.C.  
Refusal Date30-Sep-2010  
FDA DistrictLOS-DO  
Entry/doc/line/sfx AEK-9640386-6/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
REGISTERED   502(o), 801(a)(3); MISBRANDING   It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).