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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 AEK-7145129-4/3/2

Manufacturer FEI3005980375
Manufacturer NameSheetal Ayuverda  
Manufacturer Address line 1Shop No2 Harmyadam Ram Mandir Road  
Manufacturer Address line 2  
Manufacturer's CityVile Parle  
Manufacturer Province/State  
Manufacturer Country/AreaIndia  
Product Code62UDA99  
FDA Product DescriptionANTI-TUSSIVE/COLD N.E.C.  
Refusal Date06-Dec-2006  
FDA DistrictNYK-DO  
Entry/doc/line/sfx AEK-7145129-4/3/2
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).