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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 UPS-3978859-7/23/1

Manufacturer FEI3003537860
Manufacturer NameBDF  
Manufacturer Address line 1Beiersdorf AG  
Manufacturer Address line 2  
Manufacturer's CityHamburg  
Manufacturer Province/State  
Manufacturer Country/AreaGermany  
Product Code53LC10  
Importer's Product DescriptionHYALURON-FILLER EYES CONTOUR  
Refusal Date22-Nov-2011  
FDA DistrictPHI-DO  
Entry/doc/line/sfx UPS-3978859-7/23/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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.