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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 KM6-0056593-1/14/1

Manufacturer FEI3009059280
Manufacturer NameEtc International  
Manufacturer Address line 1House #163/D,Road #3,Mohammadihousing  
Manufacturer Address line 2  
Manufacturer's CityDhaka  
Manufacturer Province/State  
Manufacturer Country/AreaBangladesh  
Product Code53IG01  
Importer's Product DescriptionMAGIC TOOTH POWDER  
Refusal Date14-Sep-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx KM6-0056593-1/14/1
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.