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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 ARM-0062403-7/186/1


Manufacturer FEI3003615307
Manufacturer NameEminence Organic Skin Care Inc.  
Manufacturer Address line 11715 Cook Street, Unit 201  
Manufacturer Address line 2  
Manufacturer's CityVancouver  
Manufacturer Province/StateBC  
Manufacturer Country/AreaCanada  
Product Code53LD09  
Importer's Product DescriptionARNICA ANTI-REDNESS BOOSTER 2OZ  
Refusal Date20-Apr-2012  
FDA DistrictSEA-DO  
Entry/doc/line/sfx ARM-0062403-7/186/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
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