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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 112-3706464-2/111/1


Manufacturer FEI3005476323
Manufacturer NameGlaxo Smithklineq  
Manufacturer Address line 1Bussamtten 1  
Manufacturer Address line 2  
Manufacturer's CityBuehl  
Manufacturer Province/State  
Manufacturer Country/AreaGermany  
Product Code53ID02  
FDA Product DescriptionMOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)  
Refusal Date07-Oct-2011  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-3706464-2/111/1
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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