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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 FV4-5038374-3/2/3


Manufacturer FEI3007292644
Manufacturer NameKim Jeong Moon Aloe Co., Ltd.  
Manufacturer Address line 1Baekjae B/D. 1580-10,  
Manufacturer Address line 2  
Manufacturer's CitySeoul  
Manufacturer Province/State  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53LC10  
Importer's Product DescriptionBELUCIE LUXURY - AGE BALANCING/ANTI-AGING CREAM  
Refusal Date14-Jun-2012  
FDA DistrictSAN-DO  
Entry/doc/line/sfx FV4-5038374-3/2/3
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
DIRECTIONS   502(f)(1), 801(a)(3); MISBRANDING   The article appears to lack adequate directions for use.  
NO ENGLISH   502(c); 801(a)(3) ;MISBRANDING   Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).  
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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