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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 D84-0057887-7/1/1

Manufacturer FEI3000132611
Manufacturer NameJordan Co For Marketing Dead Sea Pr  
Manufacturer Address line 1Po Box 212307  
Manufacturer Address line 2  
Manufacturer's CityAmman  
Manufacturer Province/State  
Manufacturer Country/AreaJordan  
Product Code53BY01  
Importer's Product DescriptionBATH SALTS  
Refusal Date15-Oct-2012  
FDA DistrictSJN-DO  
Entry/doc/line/sfx D84-0057887-7/1/1
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.