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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 279-3219973-3/1/20

Manufacturer FEI3008786737
Manufacturer NameEurodep  
Manufacturer Address line 15 9 Rue Antoine De Saint Exupery  
Manufacturer Address line 2  
Manufacturer's CityCompans  
Manufacturer Province/State  
Manufacturer Country/AreaFrance  
Product Code53LD10  
Importer's Product DescriptionSERUM REGENERATION SAMPLE  
Refusal Date01-Nov-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx 279-3219973-3/1/20
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.