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Import Refusal Report

Refusal Details as Recorded in OASIS by FDA

for Refusal 606-0104516-8/1/7/


Manufacturer FEI3005221966  
Manufacturer NameNouvelle Parfumerie Gandour  
Manufacturer Address line 1Zone Industrielle Youpougon 01 Bp 4387  
Manufacturer Address line 2  
Manufacturer's CityAbidjan  
Manufacturer Province/State  
Manufacturer CountryIvory Coast  
Product Code63VBY02  
Importer's Product DescriptionSAVON EXTRA CLAIRE  
Refusal Date12-Nov-2008  
FDA DistrictFLA-DO  
Entry/doc/line/sfx 606-0104516-8/1/7/  
CarrierHAPAG LLOYD A G  
Bill of Lading  
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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