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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 EMO-0020612-9/5/1


Manufacturer FEI3007554929
Manufacturer NameDead Sea Premier Cosmetics Lab  
Manufacturer Address line 121 Hashaked St  
Manufacturer Address line 2  
Manufacturer's CityShoham  
Manufacturer Province/State  
Manufacturer Country/AreaIsrael  
Product Code53LC07  
Importer's Product DescriptionNIGHT CREAM  
Refusal Date14-Mar-2013  
FDA DistrictSEA-DO  
Entry/doc/line/sfx EMO-0020612-9/5/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
COLOR LBLG   602(e), 801(a)(3); MISBRANDING   The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.  
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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