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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 201-1907853-2/2/1


Manufacturer FEI3007826936
Manufacturer NameTan Nhat Huong Co Ltd  
Manufacturer Address line 161a Tran Quang Dieu Street  
Manufacturer Address line 2  
Manufacturer's CityHo Chi Minh City  
Manufacturer Province/State  
Manufacturer Country/AreaVietnam  
Product Code53IJ01  
FDA Product DescriptionDENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)  
Refusal Date02-May-2012  
FDA DistrictFLA-DO  
Entry/doc/line/sfx 201-1907853-2/2/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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).  
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