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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 U14-0070217-5/7/1

Manufacturer FEI3003489976
Manufacturer NameCia Universal De Perfumeria Francesa Sa  
Manufacturer Address line 11 St Bldg No 55  
Manufacturer Address line 2  
Manufacturer's CityColon Free Zone  
Manufacturer Province/State  
Manufacturer Country/AreaPanama  
Product Code53GC99  
Importer's Product DescriptionSKIN PREPARATIONS  
Refusal Date07-Feb-2013  
FDA DistrictFLA-DO  
Entry/doc/line/sfx U14-0070217-5/7/1
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.