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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 112-4397009-5/1/1


Manufacturer FEI3002948269
Manufacturer NameMerial  
Manufacturer Address line 129 Av. Tony Garnier  
Manufacturer Address line 2  
Manufacturer's CityLyon  
Manufacturer Province/State  
Manufacturer Country/AreaFrance  
Product Code68YIS99  
FDA Product DescriptionOTHER ANIMAL, N.E.C. ANIMAL DRUGS N.E.C.  
Refusal Date02-Oct-2008  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-4397009-5/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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)]  
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