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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 101-3137757-4/6/1

Manufacturer FEI3006658077
Manufacturer NameRamkrishna Vidyut Ayurvedic Pharmacy, Pune(M.S.)  
Manufacturer Address line 1"Geetai Sanjul", Office No1  
Manufacturer Address line 23rd Floor  
Manufacturer's CityKothrud, Pune  
Manufacturer Province/State  
Manufacturer Country/AreaIndia  
Product Code53FD99  
Importer's Product DescriptionHAIR OIL  
Refusal Date30-Nov-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx 101-3137757-4/6/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.