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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 112-6764768-8/1/1

Manufacturer FEI3003029000
Manufacturer NameJafra Manufactuing S.A. de C.V.  
Manufacturer Address line 1AV. La Estacada No.201  
Manufacturer Address line 2Parque Industrial Queretaro  
Manufacturer's CityC.P 76220 Santa Rosa Jauregul , Qro  
Manufacturer Province/State  
Manufacturer Country/AreaMexico  
Product Code53LC01  
Importer's Product Description875487593287 HYDRATING CREAM CLEANSER  
Refusal Date18-Apr-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-6764768-8/1/1
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).  
COSMETLBLG   5(c)(3)(B); 801(a)(3) Misbranding   It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.