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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 144-6215240-9/14/8

Manufacturer FEI3003629010
Manufacturer NameEau Zone Huiles Et Fragrances Ltee  
Manufacturer Address line 11625 Rue Chabanel O Ste 960  
Manufacturer Address line 2  
Manufacturer's CityMontreal  
Manufacturer Province/StateQC  
Manufacturer Country/AreaCanada  
Product Code53DD99  
Importer's Product DescriptionHOLD ME TIGHT GEL  
Refusal Date10-Apr-2013  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 144-6215240-9/14/8
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.