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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 112-9299745-4/1/1

Manufacturer FEI3000291939
Manufacturer NameShiseido Fine Toiretaly K.K.  
Manufacturer Address line 17-5-5 Ginza  
Manufacturer Address line 2  
Manufacturer's CityChuo-Ku  
Manufacturer Province/StateTokyo  
Manufacturer Country/AreaJapan  
Product Code53LD99  
Importer's Product Description899015856277 SKINCARE SUPER CORRECTIVE SERUM  
Refusal Date12-Oct-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-9299745-4/1/1
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.