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 071-0192892-2/8/221

Manufacturer FEI1000270679
Manufacturer NameLaboratorium Kosmetyczne Dr Irena E  
Manufacturer Address line 1Armii Krajowej 12  
Manufacturer Address line 2  
Manufacturer's CityPiaseczno  
Manufacturer Province/State  
Manufacturer Country/AreaPoland  
Product Code53CC04  
Importer's Product DescriptionDUO ACTIVE MOISTURIZING EYE GEL  
Refusal Date24-Jul-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 071-0192892-2/8/221
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
COSMETLBLG   5(c)(3)(B); 801(a)(3) Misbranding   It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.  
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.  
LABELING   Section 4(a); 801(a)(3) Misbranding   The article appears in violation of FPLA because of its placement, form and/or contents statement.  
-
-