• 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 201-9212201-7/1/1

Manufacturer FEI3006999111
Manufacturer NameMerz Group Services Gbbh  
Manufacturer Address line 1Ludwigstrasse 22  
Manufacturer Address line 2  
Manufacturer's CityReinheim  
Manufacturer Province/State  
Manufacturer Country/AreaGermany  
Product Code53LY06  
Importer's Product DescriptionMEDERMA  
Refusal Date21-Mar-2012  
FDA DistrictATL-DO  
Entry/doc/line/sfx 201-9212201-7/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.