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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-0002896-6/1/3

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-0002896-6/1/3
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).