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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 112-4814453-2/1/1


Manufacturer FEI3001599766
Manufacturer NameChangzhou Jiaerke Pharmaceuticals Group Crop., Ltd.  
Manufacturer Address line 1Zhenglu, Wujin  
Manufacturer Address line 2  
Manufacturer's CityChangzhou, Jiangsu  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code65JSY31  
FDA Product DescriptionPROGESTERONE (PROGESTIN)  
Refusal Date17-Nov-2011  
FDA DistrictSEA-DO  
Entry/doc/line/sfx 112-4814453-2/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
DIRECTIONS   502(f)(1), 801(a)(3); MISBRANDING   The article appears to lack adequate directions for use.  
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