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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 AEK-8890777-5/1/1

Manufacturer FEI3001599766
Manufacturer NameJiangsu Jiaerke Pharmaceuticals Group Corp., Ltd.  
Manufacturer Address line 1Sanhuangmiao, Zhenglu,  
Manufacturer Address line 2Wujin  
Manufacturer's CityChangzhou  
Manufacturer Province/StateJiangsu  
Manufacturer Country/AreaChina  
Product Code65JIY31  
Refusal Date03-Nov-2011  
FDA DistrictCIN-DO  
Entry/doc/line/sfx AEK-8890777-5/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
DIRECTIONS   502(f)(1), 801(a)(3); MISBRANDING   The article appears to lack adequate directions for use.  
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).