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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 XXX-0175939-7/1/1


Manufacturer FEI3003810459
Manufacturer NameFabrique par Rodis  
Manufacturer Address line 104 B.P. 1282  
Manufacturer Address line 2  
Manufacturer's CityAbidjan 04  
Manufacturer Province/State  
Manufacturer Country/AreaIvory Coast  
Product Code53LC03  
FDA Product DescriptionFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)  
Refusal Date14-Oct-2011  
FDA DistrictMIN-DO  
Entry/doc/line/sfx XXX-0175939-7/1/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
NO ENGLISH   502(c); 801(a)(3) ;MISBRANDING   Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).  
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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