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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 DK3-0753465-3/14/3


Manufacturer FEI3006755325
Manufacturer NameOrange Drugs Comapny  
Manufacturer Address line 166/68 Town Planning Way  
Manufacturer Address line 2Ilupeju  
Manufacturer's CityLagos  
Manufacturer Province/State  
Manufacturer Country/AreaNigeria  
Product Code53BY99  
FDA Product DescriptionOTHER BATH PREPARATIONS, N.E.C.  
Refusal Date13-Sep-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx DK3-0753465-3/14/3
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
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