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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 548-0142067-7/1/1


Manufacturer FEI3006988759
Manufacturer NameJIANGXI JIANYUAN BIOLOGICAL TECHNOLOGY CO LTD  
Manufacturer Address line 1LIANGFU INDUSTRIAL ZONE, DINGNAN COUNTY  
Manufacturer Address line 2  
Manufacturer's CityJIANHXI  
Manufacturer Province/StateCN-36  
Manufacturer Country/AreaChina  
Product Code65PDR02  
FDA Product DescriptionSILDENAFIL CITRATE (REGULATOR)  
Refusal Date05-Aug-2010  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 548-0142067-7/1/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).  
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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