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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 152 - 101 Hanjeok 2-gil  
Manufacturer Address line 2  
Manufacturer's CityKongju  
Manufacturer Province/State  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53LD06  
FDA Product DescriptionMOISTURIZING (SKIN CARE PREPARATIONS)  
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  
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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