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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 G08-0028183-7/5/4


Manufacturer FEI3009809636
Manufacturer NameShiny Face Laparotory  
Manufacturer Address line 11267 Khalif a St  
Manufacturer Address line 2  
Manufacturer's CitySharija  
Manufacturer Province/State  
Manufacturer Country/AreaUnited Arab Emirates  
Product Code53JC99  
Importer's Product DescriptionSILK COOL BODY SCREP  
Refusal Date23-Feb-2012  
FDA DistrictMIN-DO  
Entry/doc/line/sfx G08-0028183-7/5/4
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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