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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 E4G-0003348-0/16/1


Manufacturer FEI3000305925
Manufacturer NameComercial Urania Sa De Cv  
Manufacturer Address line 1Saltillo No 119 Col Exhipodromocondesa  
Manufacturer Address line 2  
Manufacturer's CityMexico  
Manufacturer Province/State  
Manufacturer Country/AreaMexico  
Product Code53LC06  
FDA Product DescriptionMOISTURIZING (SKIN CARE PREPARATIONS)  
Refusal Date21-Feb-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx E4G-0003348-0/16/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
COSMETLBLG   5(c)(3)(A); 801(a)(3) Misbranding   It appears the label does not bear the common or usual name of the cosmetic.  
POISONOUS   601(a), 801(a)(3); ADULTERATION   The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.  
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