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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 J50-0115850-8/1/5

Manufacturer FEI3007538525
Manufacturer NameSri Bhagavathy Madom  
Manufacturer Address line 1Ayurveda Nikethhanam  
Manufacturer Address line 2  
Manufacturer's CityAyyanthole Thrissur 3  
Manufacturer Province/State  
Manufacturer Country/AreaIndia  
Product Code53LY99  
Importer's Product DescriptionMASSAGE OIL 100 ML  
Refusal Date01-Dec-2011  
FDA DistrictATL-DO  
Entry/doc/line/sfx J50-0115850-8/1/5
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.