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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-9012524-6/1/2


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 Code53GC99  
Importer's Product DescriptionFACIAL CREAM ACGLICOLIC CLASSIC GEL FORTE  
Refusal Date25-Sep-2012  
FDA DistrictSJN-DO  
Entry/doc/line/sfx ENM-9012524-6/1/2
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
CSTIC LBLG   602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING   The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.  
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