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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 D40-0340867-9/1/1


Manufacturer FEI3004512562
Manufacturer NamePph Eveline Cosmetics  
Manufacturer Address line 1Ul. Zythnia 19  
Manufacturer Address line 2  
Manufacturer's CityLesznowola  
Manufacturer Province/State  
Manufacturer Country/AreaPoland  
Product Code53LF03  
Importer's Product DescriptionANTI CELLULITE CREAM  
Refusal Date04-Jan-2013  
FDA DistrictCHI-DO  
Entry/doc/line/sfx D40-0340867-9/1/1
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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