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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 112-4147514-9/1/1


Manufacturer FEI3005356157
Manufacturer NameGlaxcosmithkline  
Manufacturer Address line 1Bussmatten 1  
Manufacturer Address line 2  
Manufacturer's CityBuhl  
Manufacturer Province/State  
Manufacturer Country/AreaGermany  
Product Code53ID01  
FDA Product DescriptionDENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)  
Refusal Date16-Nov-2011  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-4147514-9/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
LABELING   Section 4(a); 801(a)(3) Misbranding   The article appears in violation of FPLA because of its placement, form and/or contents statement.  
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