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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 G76-0125868-2/6/1

Manufacturer FEI3005727577
Manufacturer NameGamma Croma S.P.A.  
Manufacturer Address line 1Strada Statale Paullese 415  
Manufacturer Address line 2Km 29  
Manufacturer's CityVaiano Cremasco  
Manufacturer Province/State  
Manufacturer Country/AreaItaly  
Product Code53CH03  
Importer's Product DescriptionEYESHADOW SMOKY PALETTE  
Refusal Date20-Oct-2011  
FDA DistrictNYK-DO  
Entry/doc/line/sfx G76-0125868-2/6/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis Yes  
Violation Code Section Charge Statement
POISONOUS   601(a), 801(a)(3); ADULTERATION   The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.