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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 DO2-0294442-0/1/1

Manufacturer FEI1000578826
Manufacturer NameKemon Spa  
Manufacturer Address line 1Via E Mattei 35  
Manufacturer Address line 2  
Manufacturer's CitySangiustino  
Manufacturer Province/StateFn  
Manufacturer Country/AreaItaly  
Product Code53EA02  
Importer's Product DescriptionFIX SPRAY  
Refusal Date12-Apr-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx DO2-0294442-0/1/1
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.