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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 551-9842108-8/1/4

Manufacturer FEI3006172393
Manufacturer NameLaboratoire Dr. Renaud  
Manufacturer Address line 12805 Place Louis R Renaud  
Manufacturer Address line 2  
Manufacturer's CityLaval  
Manufacturer Province/StateQc  
Manufacturer Country/AreaCanada  
Product Code53LC10  
Importer's Product DescriptionEXCOLL PROFESTIONAL TREAMENT  
Refusal Date06-Jun-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 551-9842108-8/1/4
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.