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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 112-5596073-4/1/1


Manufacturer FEI3004828308
Manufacturer NameMerck & Co  
Manufacturer Address line 11131 Rue Meighen  
Manufacturer Address line 2  
Manufacturer's CityPierrefonds  
Manufacturer Province/StateQUEBEC  
Manufacturer Country/AreaCanada  
Product Code65RDK12  
Importer's Product Description850138454920 OPHTHALMIC DROPS  
Refusal Date05-Jan-2005  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 112-5596073-4/1/1
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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