Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Import Refusal Report
  • Print
  • Share
  • E-mail
-

Refusal Details as Recorded in OASIS by FDA

for Refusal FV4-5038374-3/2/4

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 Code53LC06  
Importer's Product DescriptionBELUCIE LUXURY - MOISTURZING NIGHT/DAY CREAM  
Refusal Date05-Jul-2012  
FDA DistrictSAN-DO  
Entry/doc/line/sfx FV4-5038374-3/2/4
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
CSTIC LBLG   602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING   The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.  
DIRECTIONS   502(f)(1), 801(a)(3); MISBRANDING   The article appears to lack adequate directions for use.  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.  
-
-