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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 112-8350653-7/1/1

Manufacturer FEI3005669319
Manufacturer NameEncube Ethicals Pvt. Ltd.  
Manufacturer Address line 1Plot No. C1-C4 and C17-C20, Madkaim  
Manufacturer Address line 2Industrial Est., Madkhaim, Post:Mardol  
Manufacturer's CityPonda  
Manufacturer Province/StateGOA  
Manufacturer Country/AreaIndia  
Product Code66VDO99  
Importer's Product Description420166692875 TRIPAL CARE PROTEDCTIVE CREAM  
Refusal Date15-Sep-2010  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-8350653-7/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
DRUG NAME   502(e)(1); 801(a)(3); Misbranding   The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.