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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 245-1227998-5/1/1


Manufacturer FEI3007220107
Manufacturer NameWuhan Yigao Industries Co., Ltd.  
Manufacturer Address line 1Rm E-2207 Hua-shi-ru-shang  
Manufacturer Address line 2GARDEN NO.218 HONGKONG ROAD  
Manufacturer's CityWUHAN  
Manufacturer Province/StateCN-42  
Manufacturer Country/AreaChina  
Product Code65CBY99  
Importer's Product DescriptionBLOOD TONIC SYRUP  
Refusal Date17-Nov-2011  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 245-1227998-5/1/1
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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