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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 115-0052341-7/4/1

Manufacturer FEI3005172271
Manufacturer NameHouseholds & Tolietires Manufacturi  
Manufacturer Address line 1P.O. Box 1027  
Manufacturer Address line 2  
Manufacturer's CityAmman  
Manufacturer Province/State  
Manufacturer Country/AreaJordan  
Product Code61HBY99  
Importer's Product DescriptionANTIBACTERIAL HAND SANITIZER  
Refusal Date06-Oct-2005  
FDA DistrictCIN-DO  
Entry/doc/line/sfx 115-0052341-7/4/1
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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