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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 336-3323655-3/3/5


Manufacturer FEI3008961863
Manufacturer NameSamara For Dead Sea Products  
Manufacturer Address line 1Po Box 55  
Manufacturer Address line 2  
Manufacturer's CitySahab  
Manufacturer Province/StateAmman  
Manufacturer Country/AreaJordan  
Product Code53LD08  
FDA Product DescriptionPASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)  
Refusal Date04-Nov-2011  
FDA DistrictMIN-DO  
Entry/doc/line/sfx 336-3323655-3/3/5
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
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