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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 551-0332392-5/10/1

Manufacturer FEI3009319095
Manufacturer NamePearl & Daisy Natural Soap Company Inc.  
Manufacturer Address line 1475 Macelmon Road Unit 5  
Manufacturer Address line 2  
Manufacturer's CityDebert  
Manufacturer Province/StateNS  
Manufacturer Country/AreaCanada  
Product Code53LD01  
Importer's Product DescriptionBODY BALM LOTION  
Refusal Date20-Sep-2012  
FDA DistrictNWE-DO  
Entry/doc/line/sfx 551-0332392-5/10/1
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.