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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 E10-0207197-8/3/1

Manufacturer FEI3007132654
Manufacturer NameParamount Agencies  
Manufacturer Address line 1Sadar Center 322 Serai Road  
Manufacturer Address line 2  
Manufacturer's CityKarachi  
Manufacturer Province/State  
Manufacturer Country/AreaPakistan  
Product Code53ED01  
Importer's Product DescriptionHAIR OIL  
Refusal Date20-Dec-2011  
FDA DistrictATL-DO  
Entry/doc/line/sfx E10-0207197-8/3/1
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.