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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 112-4667478-7/1/1


Manufacturer FEI3005200199
Manufacturer NameSu Zhou Vitajoy BioTech  
Manufacturer Address line 11607 1608 No 22 Shishanlu  
Manufacturer Address line 2  
Manufacturer's CitySuzhoush┬┐  
Manufacturer Province/StateJiangsusheng  
Manufacturer Country/AreaChina  
Product Code62JAR09  
FDA Product DescriptionLEVODOPA (ANTI-PARKINSONIAN)  
Refusal Date15-Nov-2011  
FDA DistrictSEA-DO  
Entry/doc/line/sfx 112-4667478-7/1/1
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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