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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 AEF-0014148-3/1/1

Manufacturer FEI3009350651
Manufacturer NameManchurian Chrysanthemum Poit And Abalone  
Manufacturer Address line 1Nohwaup 994  
Manufacturer Address line 2  
Manufacturer's CityWando  
Manufacturer Province/StateChonnam  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53LD03  
Importer's Product DescriptionBB CREAM  
Refusal Date23-Apr-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx AEF-0014148-3/1/1
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.