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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 MR5-2024449-9/4/1/C

Manufacturer FEI3009625420
Manufacturer NameShirley Chemical Corp.  
Manufacturer Address line 1P.O. Box 1004  
Manufacturer Address line 2  
Manufacturer's CityTaipei  
Manufacturer Province/State  
Manufacturer Country/AreaTaiwan  
Product Code53LD01  
Importer's Product DescriptionHENNA  
Refusal Date22-Jan-2013  
FDA DistrictSEA-DO  
Entry/doc/line/sfx MR5-2024449-9/4/1/C
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.