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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 ENM-9012524-6/1/42

Manufacturer FEI3008878813
Manufacturer NameSESDERMA SL  
Manufacturer Address line 1Pol. Industrial Rafelbunol  
Manufacturer Address line 2Calle Massamagrell 5  
Manufacturer's CityRafelbu┬┐ol  
Manufacturer Province/StateValencia  
Manufacturer Country/AreaSpain  
Product Code53LC99  
Importer's Product DescriptionFACIAL CREAM FACTOR G  
Refusal Date25-Sep-2012  
FDA DistrictSJN-DO  
Entry/doc/line/sfx ENM-9012524-6/1/42
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
LABELING   Section 4(a); 801(a)(3) Misbranding   The article appears in violation of FPLA because of its placement, form and/or contents statement.