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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 AMG-0088948-9/2/2/A

Manufacturer FEI3001621087
Manufacturer NameAlcantara Espana Sa  
Manufacturer Address line 1Calle Arribes del Duero, 57  
Manufacturer Address line 2BJ Pol. Ind. El Montalvo II  
Manufacturer's CitySalamanca  
Manufacturer Province/StateSalamanca  
Manufacturer Country/AreaSpain  
Product Code53ED06  
Refusal Date09-Nov-2012  
FDA DistrictFLA-DO  
Entry/doc/line/sfx AMG-0088948-9/2/2/A
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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).