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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 112-7245075-5/1/2

Manufacturer FEI3004611628
Manufacturer NameTaiyen Biotech Co., Ltd.  
Manufacturer Address line 1No. 297, Sec. 1, Chen-Kang Road  
Manufacturer Address line 2  
Manufacturer's CityTainan  
Manufacturer Province/State  
Manufacturer Country/AreaTaiwan  
Product Code53LC01  
Importer's Product Description876044201604 DIAMOND BRIGHT WHITENING ESSENCE II  
Refusal Date24-May-2012  
FDA DistrictSEA-DO  
Entry/doc/line/sfx 112-7245075-5/1/2
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.