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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 N16-1049214-5/3/3

Manufacturer FEI3004795940
Manufacturer NamePaloma Dead Sea, Ltd.  
Manufacturer Address line 138900 Caesarea  
Manufacturer Address line 2  
Manufacturer's CityCaesarea  
Manufacturer Province/StateIL-NOTA  
Manufacturer Country/AreaIsrael  
Product Code53ED06  
Importer's Product DescriptionDR KREMER TREATMENT SHAMPOO - OILY  
Refusal Date10-Nov-2011  
FDA DistrictSEA-DO  
Entry/doc/line/sfx N16-1049214-5/3/3
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.