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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 112-1355067-2/1/1

Manufacturer FEI3009174358
Manufacturer NameKolmar Korea Co., Ltd.  
Manufacturer Address line 11596-3, Seocho-Dong, Seocho-Gu  
Manufacturer Address line 2  
Manufacturer's CitySeoul  
Manufacturer Province/State  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53LD06  
Importer's Product Description800255455230 COSMETIC LOTION  
Refusal Date20-Mar-2013  
FDA DistrictSEA-DO  
Entry/doc/line/sfx 112-1355067-2/1/1
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.