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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 112-5188917-1/7/1


Manufacturer FEI3005235096
Manufacturer NameAMORE PACIFIC CORPORATION  
Manufacturer Address line 1181, 2GA HANGANG-RO  
Manufacturer Address line 2  
Manufacturer's CityYONGSAN-GU  
Manufacturer Province/StateKr-11  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53LD06  
Importer's Product DescriptionCONTOUR SERUM  
Refusal Date17-Jan-2012  
FDA DistrictDET-DO  
Entry/doc/line/sfx 112-5188917-1/7/1
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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