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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 AEK-0289584-1/1/2

Manufacturer FEI3009790755
Manufacturer NameCarlos Arturo Guarin  
Manufacturer Address line 1Cra 4 A # 62 N-102  
Manufacturer Address line 2  
Manufacturer's CityCali  
Manufacturer Province/State  
Manufacturer Country/AreaColombia  
Product Code53BD01  
Importer's Product DescriptionEUROLICITHIN CREAM FOR MASSAGE  
Refusal Date30-Oct-2012  
FDA DistrictFLA-DO  
Entry/doc/line/sfx AEK-0289584-1/1/2
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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.