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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 112-3705507-4/1/2

Manufacturer FEI3003779729
Manufacturer NameNerova S.A.  
Manufacturer Address line 1Beruti 1341 Martinez Prov.Bs.As.  
Manufacturer Address line 2  
Manufacturer's CityBuenos Aires  
Manufacturer Province/State  
Manufacturer Country/AreaArgentina  
Product Code53YY99  
Importer's Product Description847069546260-LIP STICK  
Refusal Date23-Aug-2004  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-3705507-4/1/2
FDA Sample AnalysisNo  
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).