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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 NS1-0007632-3/1/32

Manufacturer FEI3004003042
Manufacturer NameProcosmet Srl  
Manufacturer Address line 1Via Della Solidarieta 29  
Manufacturer Address line 2  
Manufacturer's CityCrespellano  
Manufacturer Province/StateBO  
Manufacturer Country/AreaItaly  
Product Code53FD03  
Importer's Product DescriptionACTIVE DAY SYSTEM  
Refusal Date15-Dec-2011  
FDA DistrictFLA-DO  
Entry/doc/line/sfx NS1-0007632-3/1/32
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).