• 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 F57-3803453-0/1/1

Manufacturer FEI3004737602
Manufacturer NameWillard Manufacturing Inc.  
Manufacturer Address line 15295 John Lucas Drive  
Manufacturer Address line 2  
Manufacturer's CityBurlington  
Manufacturer Province/StateOn  
Manufacturer Country/AreaCanada  
Product Code53ED06  
Refusal Date26-Mar-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx F57-3803453-0/1/1
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).