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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 UPS-4546791-1/9/2

Manufacturer FEI3009503825
Manufacturer NameLucas Meyer Cosmetics Canada  
Manufacturer Address line 12600 Boul Laurier  
Manufacturer Address line 2  
Manufacturer's CityQuebec  
Manufacturer Province/StateQC  
Manufacturer Country/AreaCanada  
Product Code53PD99  
Importer's Product DescriptionALDAVINE 5X  
Refusal Date22-Jan-2013  
FDA DistrictNWE-DO  
Entry/doc/line/sfx UPS-4546791-1/9/2
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.