• 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 BJI-0007644-5/1/1/B

Manufacturer FEI3009022483
Manufacturer NameDermalab S.A.  
Manufacturer Address line 1Seestrasse 59  
Manufacturer Address line 2  
Manufacturer's CityErlenbach Zh  
Manufacturer Province/StateZh  
Manufacturer Country/AreaSwitzerland  
Product Code53LC03  
Importer's Product DescriptionFACIAL CREME  
Refusal Date22-Nov-2011  
FDA DistrictATL-DO  
Entry/doc/line/sfx BJI-0007644-5/1/1/B
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).