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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 112-7002580-5/1/2

Manufacturer FEI3007486356
Manufacturer NameFrancisco R Nunez  
Manufacturer Address line 1C 5 57 Bello Cos  
Manufacturer Address line 2  
Manufacturer's CityPuerto Plata  
Manufacturer Province/State  
Manufacturer Country/AreaDominican Republic  
Product Code60DIY99  
Importer's Product Description406021989886-ADRENOCORTICAL STEROID  
Refusal Date05-Jan-2011  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-7002580-5/1/2
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.