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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 112-7806950-0/1/3

Manufacturer FEI3009565045
Manufacturer NameBiotarin  
Manufacturer Address line 1Stadionstrabe 1 C  
Manufacturer Address line 2  
Manufacturer's CityBambach  
Manufacturer Province/State  
Manufacturer Country/AreaAustria  
Product Code53LC99  
Importer's Product Description793571049130 ANTI CELLULITE  
Refusal Date03-Jul-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-7806950-0/1/3
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NO ENGLISH   502(c); 801(a)(3);Misbranding   Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.