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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 112-7052064-1/4/1/C

Manufacturer FEI3002054792
Manufacturer NameEts Diana De Beaute  
Manufacturer Address line 1P.o. Box 11-7599  
Manufacturer Address line 2Riad El Solh  
Manufacturer's CityBeirut  
Manufacturer Province/State  
Manufacturer Country/AreaLebanon  
Product Code53LC99  
Importer's Product Description496817227761 BODY CREAM  
Refusal Date11-May-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-7052064-1/4/1/C
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.