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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 H87-0197733-7/1/1

Manufacturer FEI3005277168
Manufacturer NamePROSA productos naturales S.A. de C.V.  
Manufacturer Address line 1Cda. Sur 57 No. 174  
Manufacturer Address line 2Colonia Transito  
Manufacturer's CityMexico D.F.  
Manufacturer Province/StateMX-MEX  
Manufacturer Country/AreaMexico  
Product Code53CD99  
Importer's Product DescriptionEYE MASCARA 4 IN ONE MAMEY SEED  
Refusal Date22-Aug-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx H87-0197733-7/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis Yes  
Violation Code Section Charge Statement
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.