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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 J50-0115850-8/1/7


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  
FDA Product DescriptionOTHER SKIN CARE PREPARATIONS, N.E.C.  
Refusal Date01-Dec-2011  
FDA DistrictATL-DO  
Entry/doc/line/sfx J50-0115850-8/1/7
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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