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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 NF7-2121710-9/1/4

Manufacturer FEI3003912465
Manufacturer NameLaboratorios Pro-Medic Dermatologico S.L.  
Manufacturer Address line 1Avenida Diagonal , 445  
Manufacturer Address line 2  
Manufacturer's CityBarcelona  
Manufacturer Province/State  
Manufacturer Country/AreaSpain  
Product Code53LC01  
Importer's Product DescriptionHOMEOCEL  
Refusal Date04-Dec-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx NF7-2121710-9/1/4
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).