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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 201-1501582-6/1/6


Manufacturer FEI3005747093
Manufacturer NameCreative Labs Ltd  
Manufacturer Address line 1138 Alenbi Street  
Manufacturer Address line 2  
Manufacturer's CityTel-Aviv  
Manufacturer Province/State  
Manufacturer Country/AreaIsrael  
Product Code66VDJ99  
FDA Product DescriptionMISCELLANEOUS PATENT MEDICINES, ETC.  
Refusal Date30-Sep-2006  
FDA DistrictLOS-DO  
Entry/doc/line/sfx 201-1501582-6/1/6
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).  
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