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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 BXM-0008066-2/1/1


Manufacturer FEI3008613174
Manufacturer NameSuifan'S Medicine Company  
Manufacturer Address line 1Unit 11, 15th Floor, Honour Industrial  
Manufacturer Address line 2  
Manufacturer's CityChai Wanchai Wan  
Manufacturer Province/State  
Manufacturer Country/AreaHong Kong SAR  
Product Code53DD02  
Importer's Product DescriptionSUIFAN'S KWANG TZE SOLUTION  
Refusal Date26-Oct-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx BXM-0008066-2/1/1
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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