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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 112-4565495-4/1/2/B

Manufacturer FEI3005356157
Manufacturer NameGlaxcosmithkline  
Manufacturer Address line 1Bussmatten 1  
Manufacturer Address line 2  
Manufacturer's CityBuhl  
Manufacturer Province/State  
Manufacturer Country/AreaGermany  
Product Code53IG01  
Importer's Product Description797620211713 MOUTHWASH  
Refusal Date05-Dec-2011  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-4565495-4/1/2/B
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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.