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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 BYA-0124248-6/23/1

Manufacturer FEI3006707635
Manufacturer NameAMK Food Export (Pvt) Ltd  
Manufacturer Address line 162, Katuwana Industrial Zone  
Manufacturer Address line 2Homagama  
Manufacturer's CityHomagama  
Manufacturer Province/StateColombo  
Manufacturer Country/AreaSri Lanka  
Product Code53ED99  
Importer's Product DescriptionKUMARIKA HAIR OIL  
Refusal Date29-Jan-2013  
FDA DistrictLOS-DO  
Entry/doc/line/sfx BYA-0124248-6/23/1
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.