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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 BXH-0003106-7/8/1

Manufacturer FEI3007825926
Manufacturer NameLabocont Industrial  
Manufacturer Address line 1Calle Felipe Vicini Perdomo No 130  
Manufacturer Address line 2  
Manufacturer's CitySanto Domingo  
Manufacturer Province/State  
Manufacturer Country/AreaDominican Republic  
Product Code60LBY99  
FDA Product DescriptionANALGESIC, N.E.C.  
Refusal Date02-Oct-2009  
FDA DistrictSJN-DO  
Entry/doc/line/sfx BXH-0003106-7/8/1
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.