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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 is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies. [Adulteration, Section 501(a)(5)]