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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-5644676-4/1/1/C


Manufacturer FEI3004069985
Manufacturer NameBella Co. Ltd.  
Manufacturer Address line 11fl, No.105, Jinglong St. Wenshan  
Manufacturer Address line 2  
Manufacturer's CityTaipei  
Manufacturer Province/State  
Manufacturer Country/AreaTaiwan  
Product Code53CY06  
Importer's Product DescriptionCOATING SEALENT/EYELASH TONIC ESSE-- EYELASH EXTENSIONS, GRANADA HILLS  
Refusal Date14-Mar-2012  
FDA DistrictCIN-DO  
Entry/doc/line/sfx UPS-5644676-4/1/1/C
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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