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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-6449650-1/12/1

Manufacturer FEI3008855006
Manufacturer NameAromatic Apothecary  
Manufacturer Address line 1243 Lower Main Road  
Manufacturer Address line 2  
Manufacturer's CityJohannesburg  
Manufacturer Province/StateWitwatersrand  
Manufacturer Country/AreaSouth Africa  
Product Code53YD99  
Importer's Product DescriptionCONGESTO-K KIDDIE RUB  
Refusal Date18-Apr-2013  
FDA DistrictCHI-DO  
Entry/doc/line/sfx UPS-6449650-1/12/1
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.