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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 231-2450758-7/1/1

Manufacturer FEI3008922788
Manufacturer NameHainan Jiahua Marine Products Bio  
Manufacturer Address line 1Wenqing Av. Qinglan Development  
Manufacturer Address line 2  
Manufacturer's CityWenchang City  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code54YBE99  
Importer's Product DescriptionFINE LINE DEFENSE (AMINO ACID CAPSULE)  
Refusal Date10-Nov-2011  
FDA DistrictSEA-DO  
Entry/doc/line/sfx 231-2450758-7/1/1
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.