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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 KR4-0042649-9/16/1

Manufacturer FEI3003029000
Manufacturer NameJafra Manufactuing S.A. de C.V.  
Manufacturer Address line 1AV. La Estacada No.201  
Manufacturer Address line 2Parque Industrial Queretaro  
Manufacturer's CityC.P 76220 Santa Rosa Jauregul , Qro  
Manufacturer Province/State  
Manufacturer Country/AreaMexico  
Product Code53LC03  
Importer's Product DescriptionHAND CARE DAY CREAM SPF15 75ML  
Refusal Date11-Jun-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx KR4-0042649-9/16/1
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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