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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  
Importer's Product Description865797178891 BIOMYL 50 ML  
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  
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.