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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 BXE-0030702-3/2/1

Manufacturer FEI3004680223
Manufacturer NameTaiwan Three Mast Pharmaceutical Co.Ltd.  
Manufacturer Address line 1NO.1-3,Hisn Lo Road,An Ping Ind Area  
Manufacturer Address line 2  
Manufacturer's CityTainan  
Manufacturer Province/StateTW-TNN  
Manufacturer Country/AreaTaiwan  
Product Code53LC01  
Importer's Product DescriptionPANLAX HERBAL CREAM  
Refusal Date29-Jun-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx BXE-0030702-3/2/1
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.