• 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 UPS-6596663-8/1/1/E

Manufacturer FEI3004653456
Manufacturer NameBDF MEXICO SA DE CV  
Manufacturer Address line 1INDUSTRIAL VALLEJO NO. 509 PONIENTE 116  
Manufacturer Address line 2  
Manufacturer's CityMEXICO D.F.  
Manufacturer Province/State  
Manufacturer Country/AreaMexico  
Product Code53GK05  
Importer's Product DescriptionLIP CARE  
Refusal Date29-Jun-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx UPS-6596663-8/1/1/E
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
COLOR LBLG   403(k), 801(a)(3); MISBRANDING   The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.  
FALSE   403(a)(1), 801(a)(3); MISBRANDING   The labeling appears to be false and misleading in any particular.  
NO ENGLISH   403(f), 801(a)(3); MISBRANDING   Required label or labeling appears to not be in English per 21 CFR 101.15(c).