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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 H77-0132593-5/24/1

Manufacturer FEI3007918666
Manufacturer NameVicco Laboratories  
Manufacturer Address line 1Plot No 24 1d-2 Mologa De Orora  
Manufacturer Address line 2  
Manufacturer's CityPanaji Goa  
Manufacturer Province/StateNorth Goa Goa  
Manufacturer Country/AreaIndia  
Product Code53LC03  
Importer's Product DescriptionVICCO TURMERIC CREAM  
Refusal Date17-Sep-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx H77-0132593-5/24/1
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).