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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 336-6538593-0/2/65

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 Code53LC01  
Importer's Product DescriptionHIDROQUIN SKIN LIGHTENER GEL FORTE  
Refusal Date22-Oct-2012  
FDA DistrictATL-DO  
Entry/doc/line/sfx 336-6538593-0/2/65
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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).