• 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 EUV-0001550-5/3/11


Manufacturer FEI3003796746
Manufacturer NameLaboratorio Capilo Espa?ol C x A  
Manufacturer Address line 1Calle 19 Villa Aura  
Manufacturer Address line 2  
Manufacturer's CitySanto Domingo  
Manufacturer Province/State  
Manufacturer Country/AreaDominican Republic  
Product Code53ED05  
Importer's Product DescriptionRINSE BALSAM GL  
Refusal Date21-Dec-2011  
FDA DistrictNYK-DO  
Entry/doc/line/sfx EUV-0001550-5/3/11
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
COLOR LBLG   602(e), 801(a)(3); MISBRANDING   The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.  
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.  
-
-