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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 471-0126670-9/3/1

Manufacturer FEI3005547683
Manufacturer NameLivechem Inc  
Manufacturer Address line 1No. 1408 Seocho Dossier Vit 1 Bldg1328-7  
Manufacturer Address line 2  
Manufacturer's CitySeoul  
Manufacturer Province/State  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53ED07  
Importer's Product DescriptionPROCAVA SCALP TONIC  
Refusal Date05-Mar-2012  
FDA DistrictSEA-DO  
Entry/doc/line/sfx 471-0126670-9/3/1
FDA Sample AnalysisYes  
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.