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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 551-2451399-1/4/2


Manufacturer FEI3004146122
Manufacturer NameMaxigen Biotec, Inc.  
Manufacturer Address line 1No 17 Wuchivan 8th Rd Wugu  
Manufacturer Address line 2  
Manufacturer's CityShiang Taipei  
Manufacturer Province/State  
Manufacturer Country/AreaTaiwan  
Product Code53LY03  
Importer's Product DescriptionPROTO COLL CONCERT  
Refusal Date21-Dec-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 551-2451399-1/4/2
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
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