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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 MR5-2021006-0/1/17

Manufacturer FEI3008032516
Manufacturer NameATOMY CO.,LTD  
Manufacturer Address line 11656-15 Bongcheon-Dong, Kwanak-Gu  
Manufacturer Address line 2  
Manufacturer's CitySeoul  
Manufacturer Province/StateKR-11  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53LD06  
Importer's Product DescriptionFRESH SOLUTION  
Refusal Date23-Dec-2011  
FDA DistrictSEA-DO  
Entry/doc/line/sfx MR5-2021006-0/1/17
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.