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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 112-6696423-2/1/1

Manufacturer FEI3003846802
Manufacturer NameBioniche Animal Health Canada Inc  
Manufacturer Address line 1231 Dundas Street East  
Manufacturer Address line 2P.O. Box 1570  
Manufacturer's CityBelleville  
Manufacturer Province/StateON  
Manufacturer Country/AreaCanada  
Product Code64LQK58  
Importer's Product Description865112525036 PREGNECOL  
Refusal Date04-May-2010  
FDA DistrictDET-DO  
Entry/doc/line/sfx 112-6696423-2/1/1
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.