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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 UPS-6449650-1/4/1

Manufacturer FEI2000026312
Manufacturer NameW.Last CC  
Manufacturer Address line 140 True North Road  
Manufacturer Address line 2P.O. Box 1091, Mulbarton  
Manufacturer's CityJohannesburg  
Manufacturer Province/StateZA-GT  
Manufacturer Country/AreaSouth Africa  
Product Code53YD99  
Importer's Product DescriptionEAR-OK DROPS  
Refusal Date18-Apr-2013  
FDA DistrictCHI-DO  
Entry/doc/line/sfx UPS-6449650-1/4/1
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.