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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 KR4-0042563-2/20/1


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 Code53GD03  
Importer's Product DescriptionALWAYS MKUP PORCELAIN SPF  
Refusal Date30-May-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx KR4-0042563-2/20/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
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