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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 AEK-8489368-0/1/1

Manufacturer FEI3004077415
Manufacturer NameEbos Group  
Manufacturer Address line 1249-243 Bush Road, Albany  
Manufacturer Address line 2  
Manufacturer's CityAuckland  
Manufacturer Province/State  
Manufacturer Country/AreaNew Zealand  
Product Code53LC03  
Importer's Product DescriptionMEDICINAL MASSAGE RUB  
Refusal Date07-Dec-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx AEK-8489368-0/1/1
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.