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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 BIM-1123587-1/2/1

Manufacturer FEI3008855472
Manufacturer NameNatura-Lexa  
Manufacturer Address line 1Calle Rio Suchiate #9447 Col Marron  
Manufacturer Address line 2  
Manufacturer's CityTijuana  
Manufacturer Province/State  
Manufacturer Country/AreaMexico  
Product Code53LC03  
Importer's Product DescriptionTEPEZCOHUITE MASSAGE BODY CREAM  
Refusal Date02-Oct-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx BIM-1123587-1/2/1
FDA Sample AnalysisYes  
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)(A); 801(a)(3) Misbranding   It appears the label does not bear the common or usual name of the cosmetic.