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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 144-4159553-7/17/1

Manufacturer FEI2000046777
Manufacturer NameShantou Kanggui Co., Ltd.  
Manufacturer Address line 1South Ground Hoor,Shengye Buliding,  
Manufacturer Address line 2Shengping Industry Park,  
Manufacturer's CityShantou  
Manufacturer Province/StateCN-44  
Manufacturer Country/AreaChina  
Product Code53IC01  
Importer's Product DescriptionTOOTHPASTE - DETAILS ESTIMATED  
Refusal Date31-Jan-2012  
FDA DistrictSEA-DO  
Entry/doc/line/sfx 144-4159553-7/17/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
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).