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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 F92-0023642-5/1/1

Manufacturer FEI3003398629
Manufacturer NameAdministracion, Ventas Y Planta Industrial  
Manufacturer Address line 11251  
Manufacturer Address line 2  
Manufacturer's CityMonte Grande  
Manufacturer Province/State  
Manufacturer Country/AreaArgentina  
Product Code68FAC99  
FDA Product DescriptionOTHER ANIMAL, N.E.C. HORMONES  
Refusal Date31-Jan-2005  
FDA DistrictFLA-DO  
Entry/doc/line/sfx F92-0023642-5/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NEW VET DR   501(a)(5), 801(a)(3); ADULTERATION   The article appears to be a new animal drug which is unsafe within the meaning of Section 512(a) in that there is not in effect an approval of an applications filed with respect to its intended use or uses.