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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 H87-0197733-7/1/2


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 H87-0197733-7/1/2
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis Yes  
Charge(s)
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.  
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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