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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 BOY-0002896-6/1/7

Manufacturer FEI3009709385
Manufacturer NameCesar Gaona Jaramillo  
Manufacturer Address line 1Cdla Panorama Av Principal Cal3r  
Manufacturer Address line 2  
Manufacturer's CityGuayaquil  
Manufacturer Province/State  
Manufacturer Country/AreaEcuador  
Product Code53ED06  
Refusal Date14-Sep-2012  
FDA DistrictFLA-DO  
Entry/doc/line/sfx BOY-0002896-6/1/7
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
HELD INSAN   601(c), 801(a)(3); ADULTERATION   The cosmetic appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.