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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 WFN-8167766-4/3/1

Manufacturer FEI1000507250
Manufacturer NameBottger Gmbh  
Manufacturer Address line 1Paulsborner Str 2  
Manufacturer Address line 2  
Manufacturer's CityBerlin  
Manufacturer Province/StateBerlin  
Manufacturer Country/AreaGermany  
Product Code53BD99  
Importer's Product DescriptionSHOWER GEL  
Refusal Date06-Feb-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx WFN-8167766-4/3/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
COSM COLOR   601(e), 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).