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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 BOV-3029938-2/5/1/A

Manufacturer FEI3001651826
Manufacturer NameApivita SA  
Manufacturer Address line 1Koletti 3, Metamorphosis  
Manufacturer Address line 2  
Manufacturer's CityAthens  
Manufacturer Province/State  
Manufacturer Country/AreaGreece  
Product Code53JD99  
Importer's Product DescriptionINTIMATE CLEANSING GEL  
Refusal Date27-Mar-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx BOV-3029938-2/5/1/A
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.