• 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 201-9212282-7/1/1

Manufacturer FEI3006999111
Manufacturer NameMerz Pharma Gmbh & Co. KGaA  
Manufacturer Address line 1Ludwigstr. 22  
Manufacturer Address line 2  
Manufacturer's CityReinheim  
Manufacturer Province/StateHesse  
Manufacturer Country/AreaGermany  
Product Code53LY02  
Refusal Date12-Apr-2013  
FDA DistrictATL-DO  
Entry/doc/line/sfx 201-9212282-7/1/1
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).