• 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 112-5155000-5/33/1

Manufacturer FEI3007560141
Manufacturer NamePierre Fabre Laboratories  
Manufacturer Address line 115 Rue Theron Perie  
Manufacturer Address line 2  
Manufacturer's CityCastres  
Manufacturer Province/State  
Manufacturer Country/AreaFrance  
Product Code53LD03  
Importer's Product Description876304179978 AVENE GEL  
Refusal Date23-Jan-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-5155000-5/33/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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.