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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 112-6463991-9/1/1

Manufacturer FEI3008249071
Manufacturer NameElda Ltd  
Manufacturer Address line 1Zrinskih 62 35400 Nova Gradiska  
Manufacturer Address line 2  
Manufacturer's CityNova Gradiska  
Manufacturer Province/State  
Manufacturer Country/AreaCroatia  
Product Code53PY99  
Importer's Product Description869725525119 / E-LIQUID FLAVORING VAPOR  
Refusal Date20-Jun-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-6463991-9/1/1
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.