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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 112-1937749-2/1/4

Manufacturer FEI3002494638
Manufacturer NameBiologique Research  
Manufacturer Address line 128 - 30 Rue De La Procession  
Manufacturer Address line 2  
Manufacturer's CitySuresnes  
Manufacturer Province/State  
Manufacturer Country/AreaFrance  
Product Code53LC03  
Importer's Product Description794867645235 COCKTAIL  
Refusal Date01-Apr-2013  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-1937749-2/1/4
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.