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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 BSQ-1706564-6/1/1

Manufacturer FEI3003091092
Manufacturer NameJilin Shulan Synthetic Pharmaceutical Co. Ltd.  
Manufacturer Address line 1No. 2066 Peoples Main Road  
Manufacturer Address line 2  
Manufacturer's CityJilinshi  
Manufacturer Province/StateJilinsheng  
Manufacturer Country/AreaChina  
Product Code45LG99  
Importer's Product DescriptionCAFFEINE ANHYDROUS GRANULAR  
Refusal Date04-Nov-2011  
FDA DistrictSWI-DO  
Entry/doc/line/sfx BSQ-1706564-6/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
DRUG GMPS   501(a)(2)(B), 801(a)(3); ADULTERATION   It appears that the methods used in, or the facilities or controls used for, manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practices.