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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 ANP-0038934-7/206/1

Manufacturer FEI3005343638
Manufacturer NameDaiso Industries Co Ltd  
Manufacturer Address line 11-4-14 Higasni Yoshiyuki Saijyo  
Manufacturer Address line 2  
Manufacturer's CityHiroshima Ken  
Manufacturer Province/StateFN  
Manufacturer Country/AreaJapan  
Product Code53LY99  
Importer's Product DescriptionCOSMO WHITENING LOTION V  
Refusal Date06-Dec-2012  
FDA DistrictSAN-DO  
Entry/doc/line/sfx ANP-0038934-7/206/1
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.