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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 113-4883429-9/1/1


Manufacturer FEI3006222820
Manufacturer NameVitafor N.V.  
Manufacturer Address line 1Industriepark Noord 18  
Manufacturer Address line 2  
Manufacturer's CitySint-Niklaas  
Manufacturer Province/State  
Manufacturer Country/AreaBelgium  
Product Code69AA63  
FDA Product DescriptionVIRGINIAMYCIN CATEGORY I, MEDICATED ANIMAL FEED  
Refusal Date20-Sep-2010  
FDA DistrictCHI-DO  
Entry/doc/line/sfx 113-4883429-9/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
FEED & NAD   501(a)(6), 801(a)(3); ADULTERATION   The article appears to be an animal feed bearing or containing a new animal drug, and such animal feed is unsafe within the meaning of section 512.  
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)]  
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).  
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