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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 112-3218773-7/2/1


Manufacturer FEI3009036348
Manufacturer NameAlta Care Ltd  
Manufacturer Address line 1Piazza Di Spaga 6  
Manufacturer Address line 2  
Manufacturer's CityRome  
Manufacturer Province/State  
Manufacturer Country/AreaItaly  
Product Code53LD99  
Importer's Product Description478749054866 DERMASTIR CAVIALE CREM  
Refusal Date07-Jun-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-3218773-7/2/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
COLOR LBLG   602(e), 801(a)(3); MISBRANDING   The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.  
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).  
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